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Palamaru AL, Toader E. Assessing the Burden of Choledochian Lithiasis and Cholangiocarcinoma in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography, Using Disability-Adjusted Life Years. Health (London) 2023. [DOI: 10.4236/health.2023.151005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
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2
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An Insight on Pharmacological and Mechanical Preventive Measures of Post-ERCP PANCREATITIS (PEP)—A Review. GASTROENTEROLOGY INSIGHTS 2022. [DOI: 10.3390/gastroent13040038] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
Pancreatitis is the most common complication following endoscopic retrograde cholangio-pancreatography (ERCP). With the progress of research in many drugs and technologies, promising efficacy has been achieved in preventing post-ERCP pancreatitis (PEP). Recently, combined prevention has received more attention in order to further reduce the incidence of PEP. However, there is no review about the combined prevention of PEP. This review summarizes the medication and ERCP techniques that are used to prevent PEP and emphasizes that appropriate combination prevention approaches should be based on risk stratification.
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3
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Sperna Weiland CJ, Smeets XJ, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Kievit W, Timmerhuis HC, Umans DS, van Hooft JE, Besselink MG, van Santvoort HC, Fockens P, Bruno MJ, Drenth JP, van Geenen EJ, on behalf of the Dutch Pancreatitis Study Group . Optimal timing of rectal diclofenac in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis. Endosc Int Open 2022; 10:E246-E253. [PMID: 35295242 PMCID: PMC8920594 DOI: 10.1055/a-1675-2108] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/30/2021] [Accepted: 09/21/2021] [Indexed: 12/11/2022] Open
Abstract
Background and study aims Rectal nonsteroidal anti-inflammatory drug (NSAID) prophylaxis reduces incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Direct comparisons to the optimal timing of administration, before or after ERCP, are lacking. Therefore, we aimed to assess whether timing of rectal NSAID prophylaxis affects the incidence of post-ERCP pancreatitis. Patients and methods We conducted an analysis of prospectively collected data from a randomized clinical trial. We included patients with a moderate to high risk of developing post-ERCP pancreatitis, all of whom received rectal diclofenac monotherapy 100-mg prophylaxis. Administration was within 30 minutes before or after the ERCP at the discretion of the endoscopist. The primary endpoint was post-ERCP pancreatitis. Secondary endpoints included severity of pancreatitis, length of hospitalization, and Intensive Care Unit (ICU) admittance. Results We included 346 patients who received the rectal NSAID before ERCP and 63 patients who received it after ERCP. No differences in baseline characteristics were observed. Post-ERCP pancreatitis incidence was lower in the group that received pre-procedure rectal NSAIDs (8 %), compared to post-procedure (18 %) (relative risk: 2.32; 95% confidence interval: 1.21 to 4.46, P = 0.02). Hospital stays were significantly longer with post-procedure prophylaxis (1 day; interquartile range [IQR] 1-2 days vs. 1 day; IQR 1-4 days; P = 0.02). Patients from the post-procedure group were more likely to be admitted to the ICU (1 patient [0.3 %] vs. 4 patients [6 %]; P = 0.002). Conclusions Pre-procedure administration of rectal diclofenac is associated with a significant reduction in post-ERCP pancreatitis incidence compared to post-procedure use.
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Affiliation(s)
- Christina J. Sperna Weiland
- Department of Gastroenterology and Hepatology, Radboud Institute for Molecular Life Science, Radboudumc, Nijmegen, the Netherlands,Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands
| | - Xavier J.N.M. Smeets
- Department of Gastroenterology and Hepatology, Jeroen Bosch ziekenhuis, Den Bosch, the Netherlands
| | - Robert C. Verdonk
- Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands
| | - Alexander C. Poen
- Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, the Netherlands
| | - Abha Bhalla
- Department of Gastroenterology and Hepatology, Hagaziekenhuis, The Hague, the Netherlands
| | - Niels G. Venneman
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, the Netherlands
| | - Wietske Kievit
- Department for Health evidence, Radboudumc, Nijmegen, the Netherlands
| | - Hester C. Timmerhuis
- Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands
| | - Devica S. Umans
- Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands,Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, the Netherlands
| | - Jeanin E. van Hooft
- Department of Gastroenterology and Hepatology, Leiden University medical Centre, Leiden, the Netherlands
| | - Marc G. Besselink
- Department of Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, the Netherlands
| | - Hjalmar C. van Santvoort
- Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands ,Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Paul Fockens
- Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, the Netherlands
| | - Marco J. Bruno
- Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, the Netherlands
| | - Joost P.H. Drenth
- Department of Gastroenterology and Hepatology, Radboud Institute for Molecular Life Science, Radboudumc, Nijmegen, the Netherlands
| | - Erwin J.M. van Geenen
- Department of Gastroenterology and Hepatology, Radboud Institute for Molecular Life Science, Radboudumc, Nijmegen, the Netherlands
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Paez LF, Cury MDS, Mello MPM, Campos DND, Rodrigues BER. POST ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS PROPHYLAXIS: EVALUATION OF TWO DIFFERENT NSAID REGIMENS. ARQUIVOS DE GASTROENTEROLOGIA 2021; 58:270-275. [PMID: 34705958 DOI: 10.1590/s0004-2803.202100000-47] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/30/2020] [Accepted: 04/26/2021] [Indexed: 11/22/2022]
Abstract
BACKGROUND Endoscopic retrograde cholangiopancreatography is a widely used therapeutic modality for the pancreaticobiliary tree. However, it is responsible for the highest rates of complications among the endoscopic procedures, especially post-endoscopic retrograde cholangiopancreatography pancreatitis. The preventive methods include mechanical and pharmacological approaches, such as the use of non-steroidal anti-inflammatory drugs. OBJECTIVE To compare the efficacy of two different strategies using non-steroidal anti-inflammatory drugs for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis, and to clarify the uncertainty about the route of administration of non-steroidal anti-inflammatory drugs in the prevention of this complication. METHODS This was a prospective trial. Two therapeutic groups were compared with a control group that was composed of patients who underwent endoscopic retrograde cholangiopancreatography, performed in the same service and by the same team in the period preceding the study (historical series), without the administration of any type of prophylaxis. The first group received 100 mg rectal diclofenac. The second group received 100 mg intravenous ketoprofen. Both groups were compared, separately and jointly, with the control group. RESULTS Post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in 4.39% (12/273) of the participants. In the group without prophylaxis, the incidence was 6.89% (10/145). Among those who received intravenous ketoprofen, the incidence was 2.56% (2/78). No cases of acute post-procedural pancreatitis were observed in the group that received rectal diclofenac (0/52). Although there was no statistical difference between the therapeutic groups when they were separately analyzed, a statistical difference in the prevention of post-procedural pancreatitis was observed when they were analyzed together (P=0.037). CONCLUSION This study provides evidence for the efficacy of non-steroidal anti-inflammatory drugs in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis.
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Affiliation(s)
- Loyna Flores Paez
- Universidade Federal de Mato Grosso do Sul, Faculdade de Medicina, Campo Grande, MS, Brasil
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Márta K, Gede N, Szakács Z, Solymár M, Hegyi PJ, Tél B, Erőss B, Vincze Á, Arvanitakis M, Boškoski I, Bruno MJ, Hegyi P. Combined use of indomethacin and hydration is the best conservative approach for post-ERCP pancreatitis prevention: A network meta-analysis. Pancreatology 2021; 21:1247-1255. [PMID: 34353727 DOI: 10.1016/j.pan.2021.07.005] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2021] [Revised: 07/19/2021] [Accepted: 07/20/2021] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Post-ERCP pancreatitis (PEP) is a life-threatening complication. Given the lack of a causative treatment for pancreatitis, it is of vital importance to minimize this risk of PEP. Multi-target preventive therapy may be the best choice for PEP prevention as disease development is multifactorial. AIM We aimed to assess the efficacy of a combination of indomethacin and hydration - type and amount - for PEP prevention via a network meta-analysis. METHODS Through a systematic search in three databases, we searched all randomized controlled trials involving hydration and indomethacin and ranked the PEP preventive efficacy with a Bayesian network meta-analysis using the PRISMA for Network Meta-Analyses (PRISMA-NMA) guideline. The RoB2 tool was used for risk of bias assessment, surface under the cumulative ranking curve (SUCRA) for ranking and PROSPERO for the study protocol [reg. no. CRD42018112698]. We used risk ratios (RR) for dichotomous data with 95% credible intervals (95% CrI). RESULTS The quantitative analysis included 7559 patients from 24 randomized controlled trials. Based on the SUCRA values, a combination of lactated Ringer's and indomethacin is more effective than single therapy with a 94% certainty. The percent relative risk ratios estimate preventive efficacy 70-99% higher for combinations than single therapies. Aggressive hydration with indomethacin (SUCRA 100%) is also significantly more effective than all other interventions (percent relative effect 94.3-98.1%). CONCLUSIONS A one-hit-on-each-target therapeutic approach is recommended in PEP prevention with an easily accessible combination of indomethacin and aggressive hydration for all average and high-risk patients without contraindication.
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Affiliation(s)
- Katalin Márta
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary
| | - Noémi Gede
- Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; Institute of Bioanalysis, Medical School, University of Pécs, Pécs, Hungary
| | - Zsolt Szakács
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Margit Solymár
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Péter Jenő Hegyi
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Bálint Tél
- First Department of Pediatrics, Semmelweis University, Budapest, Hungary
| | - Bálint Erőss
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Áron Vincze
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Marianna Arvanitakis
- Gastroenterology Department, Gastrointestinal Cancer Unit, Erasme Hospital University, Brussels, Belgium
| | - Ivo Boškoski
- Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore, Italy
| | - Marco J Bruno
- Department of Gastroenterology & Hepatology, Erasmus Medical Center, University Medical Center Rotterdam, the Netherlands
| | - Péter Hegyi
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
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Espinosa W, Chiu Y, Kuo C, Liang C, Lu L, Wu C. Risk factors of post‐endoscopic retrograde cholangiopancreatography pancreatitis among living‐donor liver transplant recipients with biliary complications. ADVANCES IN DIGESTIVE MEDICINE 2021. [DOI: 10.1002/aid2.13291] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Affiliation(s)
- Wendell Espinosa
- Department of Internal Medicine Dr. Pablo O. Torre Memorial Hospital Bacolod Philippines
| | - Yi‐Chun Chiu
- Division of Hepato‐Gastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
| | - Chung‐Mou Kuo
- Division of Hepato‐Gastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
| | - Chih‐Ming Liang
- Division of Hepato‐Gastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
| | - Lung‐Sheng Lu
- Division of Hepato‐Gastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
| | - Cheng‐Kun Wu
- Division of Hepato‐Gastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
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7
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Kwak N, Yeoun D, Arroyo-Mercado F, Mubarak G, Cheung D, Vignesh S. Outcomes and risk factors for ERCP-related complications in a predominantly black urban population. BMJ Open Gastroenterol 2021; 7:bmjgast-2020-000462. [PMID: 32943462 PMCID: PMC7500190 DOI: 10.1136/bmjgast-2020-000462] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2020] [Revised: 07/27/2020] [Accepted: 08/06/2020] [Indexed: 02/06/2023] Open
Abstract
Objective There is a lack of literature on postendoscopic retrograde cholangiopancreatography (ERCP) complications in predominantly black urban populations of low socioeconomic status. The aim of this study was to determine the incidence and predictors of post-ERCP complications in this patient population. Design Retrospective review of ERCP cases performed at two hospitals from 2007 to 2017 was performed. The categories of complications evaluated were overall complications, severe or fatal complications, pancreatitis, bleeding, infection, perforation and cardiopulmonary events. Predictors of complications were determined by univariate analysis. Results A total of 1079 ERCP procedures were reviewed. There were 106 complications (9.8%). Twenty-one were severe (1.9%) and 20 were fatal (1.9%). Both post-ERCP pancreatitis (PEP) and post-ERCP bleeding occurred in 18 patients (1.7%) each. Risk factors for overall complications were male sex (OR 1.54), ASA grade IV or V (OR 2.19), prior history of PEP (OR 6.98) and pancreatic duct stent placement (OR 2.75). Those who were ASA grade III or lower (OR 0.4) or who underwent biliary stone extraction (OR 0.62) had fewer complications. PEP was more likely in those with a prior history of PEP (OR 37.6). Those with a suspected or known biliary duct stone had less frequent pancreatitis (OR 0.32). Post-ERCP bleeding was more likely in the presence of cholangitis (OR 8.72). Conclusion Outcomes of ERCP in a predominantly black urban population demonstrate a lower incidence of PEP and all-cause mortality compared with historical data reported in the general population. Potential risk factors for post-ERCP complications were identified but require larger studies for validation.
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Affiliation(s)
- Nathaniel Kwak
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
| | - Daniel Yeoun
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
| | - Fray Arroyo-Mercado
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
| | - Ghassan Mubarak
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
| | - Derrick Cheung
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
| | - Shivakumar Vignesh
- Division of Gastroenterology, SUNY Downstate Health Sciences University, Brooklyn, New York, USA
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8
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Sperna Weiland CJ, Smeets XJNM, Kievit W, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Witteman BJM, da Costa DW, van Eijck BC, Schwartz MP, Römkens TEH, Vrolijk JM, Hadithi M, Voorburg AMCJ, Baak LC, Thijs WJ, van Wanrooij RL, Tan ACITL, Seerden TCJ, Keulemans YCA, de Wijkerslooth TR, van de Vrie W, van der Schaar P, van Dijk SM, Hallensleben NDL, Sperna Weiland RL, Timmerhuis HC, Umans DS, van Hooft JE, van Goor H, van Santvoort HC, Besselink MG, Bruno MJ, Fockens P, Drenth JPH, van Geenen EJM. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol 2021; 6:350-358. [PMID: 33740415 DOI: 10.1016/s2468-1253(21)00057-1] [Citation(s) in RCA: 47] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2021] [Revised: 02/01/2021] [Accepted: 02/01/2021] [Indexed: 12/16/2022]
Abstract
BACKGROUND Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. METHODS FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. FINDINGS Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). INTERPRETATION Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. FUNDING Netherlands Organisation for Health Research and Development and Radboud University Medical Center.
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Affiliation(s)
- Christina J Sperna Weiland
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands
| | - Xavier J N M Smeets
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands
| | - Wietske Kievit
- Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands
| | - Robert C Verdonk
- Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands
| | - Alexander C Poen
- Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands
| | - Abha Bhalla
- Department of Gastroenterology and Hepatology, Hagaziekenhuis, The Hague, Netherlands
| | - Niels G Venneman
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, Netherlands
| | - Ben J M Witteman
- Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, Netherlands
| | - David W da Costa
- Department of Radiology, St Antonius Hospital, Nieuwegein, Netherlands
| | - Brechje C van Eijck
- Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, Netherlands
| | - Matthijs P Schwartz
- Department of Gastroenterology and Hepatology, Meander Medical Centre, Amersfoort, Netherlands
| | - Tessa E H Römkens
- Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, Netherlands
| | - Jan Maarten Vrolijk
- Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, Netherlands
| | - Muhammed Hadithi
- Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands
| | - Annet M C J Voorburg
- Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, Netherlands
| | - Lubbertus C Baak
- Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
| | - Willem J Thijs
- Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, Netherlands
| | - Roy L van Wanrooij
- Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
| | - Adriaan C I T L Tan
- Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands
| | - Tom C J Seerden
- Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, Netherlands
| | - Yolande C A Keulemans
- Department of Gastroenterology and Hepatology, Zuyderland Hospital, Heerlen, Netherlands
| | - Thomas R de Wijkerslooth
- Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands
| | - Wim van de Vrie
- Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, Netherlands
| | - Peter van der Schaar
- Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands
| | - Sven M van Dijk
- Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
| | - Nora D L Hallensleben
- Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, Netherlands
| | | | - Hester C Timmerhuis
- Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands
| | - Devica S Umans
- Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
| | - Jeanin E van Hooft
- Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, Netherlands
| | - Harry van Goor
- Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands
| | - Hjalmar C van Santvoort
- Department of Surgery, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands
| | - Marc G Besselink
- Department of Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
| | - Marco J Bruno
- Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, Netherlands
| | - Paul Fockens
- Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
| | - Joost P H Drenth
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands
| | - Erwin J M van Geenen
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands.
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9
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Thiruvengadam NR, Kochman ML. Emerging Therapies to Prevent Post-ERCP Pancreatitis. Curr Gastroenterol Rep 2020; 22:59. [PMID: 33188441 DOI: 10.1007/s11894-020-00796-w] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/16/2020] [Indexed: 12/14/2022]
Abstract
PURPOSE OF REVIEW The aim of this review is to evaluate emerging, novel therapies for the prevention of post-ERCP pancreatitis. RECENT FINDINGS Rectal indomethacin reduces the risk of pancreatitis in low- and average-risk patients, who comprise the majority of patients undergoing ERCP. An 8-h protocol of aggressive lactated Ringer's reduces the risk of pancreatitis in average-risk patients. Sublingual nitrate may provide additional benefit to rectal NSAIDs in preventing PEP. A tacrolimus trough > 2.5 ng/mL was recently shown to be associated with a lower risk of PEP in liver transplant patients undergoing ERCP. Routine usage of rectal indomethacin in all patients undergoing ERCP reduces the risk of PEP. Pancreatic-duct stents reduce the risk of PEP in high-risk patients. There is emerging data that aggressive hydration with lactated Ringer's and nitrates may further reduce PEP. Tacrolimus is a promising potential agent to prevent PEP but needs further clinical study.
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Affiliation(s)
- Nikhil R Thiruvengadam
- Division of Gastroenterology and Hepatology, University of California San Francisco, 513 Parnassus Avenue, S-357, Box 0538, San Francisco, CA, 94143-0538, USA. .,Gastroenterology Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
| | - Michael L Kochman
- Gastroenterology Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.,Center for Endoscopic Innovation, Research and Training, Perelman School of Medicine, Philadelphia, PA, USA
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10
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Kalantzis I, Poulou A, Papatheodorou A, Gkoumas K. Rectal versus intramuscular diclofenac in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: experience of a Greek tertiary referral center. Ann Gastroenterol 2020; 33:412-417. [PMID: 32624663 PMCID: PMC7315719 DOI: 10.20524/aog.2020.0487] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2019] [Accepted: 11/15/2019] [Indexed: 01/31/2023] Open
Abstract
Background: Independent patient-related and procedure-related factors increase the risk of pancreatitis after endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis [PEP]). Non-steroidal anti-inflammatory drugs (NSAIDs) have demonstrated efficacy in reducing the incidence of PEP. This study investigated the difference in the incidence of PEP between intramuscular and rectal prophylactic administration of diclofenac before ERCP. Methods: We performed a retrospective analysis of data from 516 patients who underwent ERCP during the period 2014-2017. The route of diclofenac administration (rectal or intramuscular), patient-related and procedure-related risk factors, as well as serum amylase levels 18 h after the endoscopic procedure and immediate bleeding during ERCP were recorded and evaluated. Results: The overall incidence of PEP was 4.5%, without significant differences between the rectal (5.2%) and intramuscular (3.9%) routes of administration. The factor that appeared to be of significance was pre-cut sphincterotomy, since patients who underwent that procedure showed a higher probability of PEP (P=0.05; odds ratio 2.67, 95% confidence interval). Intraprocedural bleeding was almost twice as frequent in the rectal compared to the intramuscular group. Pancreatic stent placement did not appear to be statistically significant in the prevention of PEP, either alone or in combination with diclofenac administration. Conclusions: The results of our study did not reveal any statistically significant difference between the rectal or intramuscular administration of diclofenac in the prevention of PEP, contradicting the results of the majority of studies and meta-analyses published so far. One of the known risk factors associated with increased risk of PEP was also confirmed.
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Affiliation(s)
- Ioannis Kalantzis
- Department of Gastroenterology (Ioannis Kalantzis, Androniki Poulou, Konstantinos Gkoumas)
| | - Androniki Poulou
- Department of Gastroenterology (Ioannis Kalantzis, Androniki Poulou, Konstantinos Gkoumas)
| | - Athanasios Papatheodorou
- Department of Radiology (Athanasios Papatheodorou), Korgialeneio-Mpenakeio Hellenic Red Cross Hospital, Athens, Greece
| | - Konstantinos Gkoumas
- Department of Gastroenterology (Ioannis Kalantzis, Androniki Poulou, Konstantinos Gkoumas)
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11
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Katoh T, Kawashima K, Fukuba N, Masuda S, Kobatake H, Masaki K, Araki Y, Kawano K, Nishi K, Takenaka M, Ishihara S, Kinoshita Y. Low-dose rectal diclofenac does not prevent post-ERCP pancreatitis in low- or high-risk patients. J Gastroenterol Hepatol 2020; 35:1247-1253. [PMID: 31788849 DOI: 10.1111/jgh.14948] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2019] [Revised: 11/13/2019] [Accepted: 11/29/2019] [Indexed: 12/16/2022]
Abstract
BACKGROUND AND AIM The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post-ERCP pancreatitis (PEP). Rectal nonsteroidal anti-inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high-risk patients. However, in contrast to high-risk patients, the role of NSAID administration in patients with low risk remains controversial. METHODS We performed a prospective, single-center, single-blinded, two-arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at-risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP. RESULTS A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk. CONCLUSIONS Prophylactic low-dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.
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Affiliation(s)
- Takao Katoh
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Kousaku Kawashima
- Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan
| | - Nobuhiko Fukuba
- Department of Internal Medicine, Izumo City General Medical Center, Izumo, Shimane, Japan
| | - Shigeto Masuda
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Hiroko Kobatake
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Kousaku Masaki
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Yasuhiro Araki
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Koichiro Kawano
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Katsuhisa Nishi
- Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan
| | - Mamoru Takenaka
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan
| | - Shunji Ishihara
- Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan
| | - Yoshikazu Kinoshita
- Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan
- Department of Medicine, Steel Memorial Hirohata Hospital, Himeji, Hyogo, Japan
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12
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Shin SH, So H, Cho S, Kim N, Baik GH, Lee SK, Park DH. The number of wire placement in the pancreatic duct and metal biliary stent as risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 2020; 35:1201-1207. [PMID: 31830336 DOI: 10.1111/jgh.14957] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/30/2019] [Revised: 11/27/2019] [Accepted: 12/08/2019] [Indexed: 01/18/2023]
Abstract
BACKGROUND AND AIM Many post-ERCP pancreatitis (PEP) risk factors, including pancreatic duct cannulation, have been identified; however, whether the number of repeated and unintentional wire placements (WPs) in the pancreatic duct during wire-guided cannulation affects PEP risk is unknown. We aimed to identify the effects of repeated WP in the pancreatic duct and other potential risk factors on PEP incidence. METHODS We retrospectively analyzed 877 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP). We examined potential patient-related and procedure-related risk factors, and PEP incidence by univariable and multivariable logistic regression analyses. RESULTS Thirty-four patients (3.9%) had PEP. Univariable analysis revealed younger age, malignant common bile duct or ampulla of Vater stricture, two or more episodes of WPs in the pancreatic duct, and metal biliary stent as risk factors for PEP. Following multivariable analysis, two or more episodes of WPs in the pancreatic duct and metal biliary stent remained in the final model. PEP did not increase significantly in case of a one episode of WP (4.0%) compared with no episode of WP in the pancreatic duct (2.7%). However, patients with two episodes of WPs had 8.0% incidence and three or more episodes of WPs had 14.3%. CONCLUSIONS A WP in the pancreatic duct and a metal biliary stent were associated with increased PEP incidence in patients undergoing ERCP. As for the pancreatic duct wire cannulation, two or more WPs considerably increased PEP incidence. This suggests that preventive measures or alternative procedures might be considered in patients with such cases during and after ERCP.
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Affiliation(s)
- Seung Hwan Shin
- Division of Gastroenterology, Departments of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | - Hoonsub So
- Division of Gastroenterology, Departments of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | | | - Nayoung Kim
- Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
| | - Sung Koo Lee
- Division of Gastroenterology, Departments of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | - Do Hyun Park
- Division of Gastroenterology, Departments of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
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13
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Abdelfatah MM, Gochanour E, Koutlas NJ, Hamed A, Harvin G, Othman MO. Rectal indomethacin reduces the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis in low-risk patients. Ann Gastroenterol 2020; 33:405-411. [PMID: 32624662 PMCID: PMC7315706 DOI: 10.20524/aog.2020.0492] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2019] [Accepted: 02/29/2020] [Indexed: 11/18/2022] Open
Abstract
Background: Evidence shows that rectal indomethacin (RI) reduces the risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients. The prophylactic role of RI in low-risk patients has not yet been identified. The objective of our study was to evaluate the impact of RI in preventing PEP in low-risk patients. Methods: A retrospective cohort study was conducted to evaluate the impact of RI in preventing PEP. RI was available starting November 2012. Patient characteristics and procedure details were collected. Results: The study population included 2238 patients who underwent ERCP (1055 in the RI group and 1183 in the control group). PEP was diagnosed in 107 patients (4.8%). In a multivariate model of consecutive patients, RI reduced the incidence of PEP by 55% (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.36-0.94; P=0.03). In a multivariate model that included 1874 (84%) low-risk patients, RI reduced the incidence of PEP by 62% (OR 0.38, 95%CI 0.19-0.74; P=0.004). Propensity-matched group analysis was performed for low-risk native papilla patients. RI reduced the incidence of PEP by 61% (OR 0.39, 95%CI 0.18-0.8; P=0.009). Conclusion: RI reduced PEP in consecutive as well as low-risk patients. RI should be administrated in consecutive patients unless contraindicated. Larger prospective studies are needed to confirm our results.
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Affiliation(s)
- Mohamed M Abdelfatah
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, University of Alabama at Birmingham, Alabama (Mohamed M. Abdelfatah).,Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, East Carolina University, Greenville, North Carolina (Mohamed M. Abdelfatah, Eric Gochanour, Nicholas J. Koutlas, Ahmed Hamed, Glenn Harvin)
| | - Eric Gochanour
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, East Carolina University, Greenville, North Carolina (Mohamed M. Abdelfatah, Eric Gochanour, Nicholas J. Koutlas, Ahmed Hamed, Glenn Harvin)
| | - Nicholas J Koutlas
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, East Carolina University, Greenville, North Carolina (Mohamed M. Abdelfatah, Eric Gochanour, Nicholas J. Koutlas, Ahmed Hamed, Glenn Harvin)
| | - Ahmed Hamed
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, East Carolina University, Greenville, North Carolina (Mohamed M. Abdelfatah, Eric Gochanour, Nicholas J. Koutlas, Ahmed Hamed, Glenn Harvin)
| | - Glenn Harvin
- Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, East Carolina University, Greenville, North Carolina (Mohamed M. Abdelfatah, Eric Gochanour, Nicholas J. Koutlas, Ahmed Hamed, Glenn Harvin)
| | - Mohamed O Othman
- Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas (Mohamed O. Othman), USA
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14
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Koskensalo V, Tenca A, Udd M, Lindström O, Rainio M, Jokelainen K, Kylänpää L, Färkkilä M. Diclofenac does not reduce the risk of acute pancreatitis in patients with primary sclerosing cholangitis after endoscopic retrograde cholangiography. United European Gastroenterol J 2020; 8:462-471. [PMID: 32213036 DOI: 10.1177/2050640620912608] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND The European Society of Gastrointestinal Endoscopy recommends rectal indomethacin or diclofenac before endoscopic retrograde cholangiopancreatography (ERCP) to prevent post-ERCP pancreatitis. However, data on the prophylactic effect in patients with primary sclerosing cholangitis (PSC) are lacking. METHODS This was a retrospective case-control study. In 2009-2018, a total of 2000 ERCPs were performed in 931 patients with PSC. Case procedures (N = 1000 after November 2013) were performed after administration of rectal diclofenac. Control procedures (N = 1000 before November 2013) were performed with the same indication but without diclofenac. Acute post-ERCP pancreatitis and other ERCP-related adverse events (AEs) were evaluated. RESULTS Post-ERCP pancreatitis developed in 49 (4.9%) procedures in the diclofenac group and 62 (6.2%) procedures in the control group (p = 0.241). No difference existed between the groups in terms of the severity of pancreatitis or any other acute AEs. The risk of pancreatitis was elevated in patients with native papilla: 11.4% in the diclofenac group and 8.7% in the control group (p = 0.294). In adjusted logistic regression, diclofenac did not reduce the risk of pancreatitis (odds ratio (OR) = 1.074, 95% confidence interval 0.708-1.629, p = 0.737). However, in generalised estimation equations with the advanced model, diclofenac seemed to diminish the risk of pancreatitis (OR = 0.503) but not significantly (p = 0.110). CONCLUSION In this large patient cohort in a low-risk unit, diclofenac does not seem to reduce the risk of post-ERCP pancreatitis in patients with PSC. The trend in the pancreatitis rate after ERCP is decreasing. The evaluation of the benefits of diclofenac among PSC patients warrants a randomised controlled study targeted to high-risk patients and procedures.
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Affiliation(s)
- Vilja Koskensalo
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland
| | - Andrea Tenca
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterology, Helsinki University Hospital, Helsinki, Finland
| | - Marianne Udd
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland
| | - Outi Lindström
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland
| | - Mia Rainio
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland
| | - Kalle Jokelainen
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterology, Helsinki University Hospital, Helsinki, Finland
| | - Leena Kylänpää
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterological Surgery, Helsinki University Hospital, Helsinki, Finland
| | - Martti Färkkilä
- Faculty of Medicine, University of Helsinki, Helsinki, Finland.,Abdominal Centre, Gastroenterology, Helsinki University Hospital, Helsinki, Finland
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15
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Avila P, Holmes I, Kouanda A, Arain M, Dai SC. Practice patterns of post-ERCP pancreatitis prophylaxis techniques in the United States: a survey of advanced endoscopists. Gastrointest Endosc 2020; 91:568-573.e2. [PMID: 31743690 DOI: 10.1016/j.gie.2019.11.013] [Citation(s) in RCA: 31] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2019] [Accepted: 11/03/2019] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS The American Society for Gastrointestinal Endoscopy recommends prophylactic pancreatic duct stent placement (PPS) and rectal nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce the incidence and severity of post-ERCP pancreatitis (PEP) in high-risk individuals and suggests that rectal indomethacin may decrease the risk and severity of PEP in average-risk individuals. The European Society for Gastrointestinal Endoscopy recommends rectal indomethacin for all patients undergoing ERCP. Previous surveys of European endoscopists revealed low adoption of PPS or rectal NSAIDs to prevent PEP. We sought to capture current practice in the prevention of PEP among endoscopists in the United States involved in advanced endoscopy fellowship programs. METHODS An anonymous online 16-item survey was e-mailed to 233 advanced endoscopists involved in advanced endoscopy fellowship programs. RESULTS Of the 233 endoscopists who were invited to participate, 62 responded (26.7%). Most respondents reported working in tertiary referral centers (57; 95.0%) and performing ERCP for greater than 5 years (44; 74.6%). All respondents (60; 100.0%) reported working with fellows. Most PPS users (41; 72.0%) reported use of PPS in high-risk patients only and using PPS for PEP in ≤25% of ERCPs (38; 64.4%). Most respondents reported using rectal NSAIDs for high-risk patients only (34; 59.7%) compared with respondents (23; 40.1%) who reported using rectal NSAIDs for prevention of PEP in average-risk patients undergoing ERCP. Most respondents (49; 83.0%) also reported using rapid intravenous fluids to prevent PEP. CONCLUSIONS Among endoscopists involved in advanced endoscopy fellowships in the United States, rectal NSAIDs are used more frequently than PPS in the prevention of PEP. Despite mounting evidence supporting the use of rectal NSAIDs to prevent PEP in average-risk patients, less than half of the respondents in this survey reported such practice.
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Affiliation(s)
- Patrick Avila
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California, USA
| | - Ian Holmes
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California, USA
| | - Abdul Kouanda
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California, USA
| | - Mustafa Arain
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California, USA
| | - Sun-Chuan Dai
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California, USA; Division of Gastroenterology, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, USA
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16
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Lyu Y, Wang B, Cheng Y, Xu Y, Du W. Comparative Efficacy of 9 Major Drugs for Postendoscopic Retrograde Cholangiopancreatography Pancreatitis: A Network Meta-Analysis. Surg Laparosc Endosc Percutan Tech 2019; 29:426-432. [PMID: 31490455 DOI: 10.1097/sle.0000000000000707] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is one of the most common complications after ERCP. The optimal drugs for reducing the risk of PEP are still unclear. This study aimed to compare the efficacy of 9 major drugs used worldwide for the prevention of PEP through a network meta-analysis. METHODS We conducted a systematic search of the literature up to October 2018 on PubMed, Embase, Web of Science, the Cochrane Central Library, and ClinicalTrials.gov. Randomized controlled trials (RCTs) comparing allopurinol, diclofenac, gabexate (GAB), glyceryl trinitrate (GTN), indomethacin, nafamostat, octreotide, somatostatin, and ulinastatin for protection against PEP were included. RESULTS Eighty-six randomized controlled trials involving 25,246 patients were included in this network meta-analysis. Results indicated that diclofenac, GAB, GTN, indomethacin, somatostatin, and ulinastatin were more effective than placebo with odds ratios ranging between 0.48 (95% credible interval, 0.26-0.86) for GAB and 0.61 (0.39-0.94) for somatostatin. However, allopurinol, nafamostat, and octreotide showed similar efficacy as placebo in reducing the risk of PEP. No significant differences were found in the efficacy between diclofenac, GAB, GTN, indomethacin, somatostatin, and ulinastatin. In terms of prognosis, GAB may be the most effective treatment (surface under the cumulative ranking curve=70.6%) and the least effective was octreotide (surface under the cumulative ranking curve=28%). CONCLUSIONS Although our analysis suggests that GAB may be the most effective drug in preventing PEP, the limitations of our study warrants more high-quality head-to-head trials of these clinical drugs in the future.
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Affiliation(s)
- Yunxiao Lyu
- Department of Hepatobiliary Surgery, Dongyang People's Hospital, Dongyang, Zhejiang, China
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17
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Perdigoto DN, Gomes D, Almeida N, Mendes S, Alves AR, Camacho E, Tomé L. Risk Factors for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in the Indomethacin Era - A Prospective Study. GE-PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2019; 26:176-183. [PMID: 31192286 DOI: 10.1159/000492313] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/24/2018] [Revised: 07/23/2018] [Indexed: 12/18/2022]
Abstract
Background and Aims Although endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure used to treat conditions affecting the biliopancreatic system, it can lead to several complications. Post-ERCP pancreatitis (PEP) is the most frequent one, with an incidence ranging from 3 to 14%. Our aim was to assess the potential risk factors associated with PEP occurrence in patients undergoing ERCP with indomethacin prophylaxis. Methods Prospective, single-center, real-world observational study (January to December 2015) with inclusion of patients submitted to ERCP, where relevant patient-related and procedure-related data had been collected. Patients had to have been admitted for a minimum of 24 h in order to establish the presence of early complications. All patients were submitted to PEP prophylaxis with 1 or 2 methods: rectal indomethacin and pancreatic duct (PD) stenting. Results A total of 188 patients who had undergone ERCP were included (52.7% women; mean age 69.2 ± 16.0 years) and PEP was diagnosed in 13 (6.9%). PEP prophylaxis consisted of indomethacin in all cases (100%) and PD stenting in 7.4%. The pancreatitis was mild in 11 patients (84.6%) and severe in the other 2. One of them died (0.5%). None of the patient-related risk factors were associated with changes in PEP probability. Of all patients, 33.0% had 2 or more procedure-related risk factors. A higher number of synchronous procedure-related risk factors showed a statistically significant correlation with PEP occurrence, p = 0.040. Conclusions The 6.9% PEP rate is considered acceptable since 33.0% patients had a medium-high risk for PEP due to challenging biliary cannulation. The total number of procedure-related risk factors seems to play a critical role in the development of PEP despite indomethacin prophylaxis.
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Affiliation(s)
- David N Perdigoto
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal.,Medical School, Coimbra University, Coimbra, Portugal
| | - Dário Gomes
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal.,Medical School, Coimbra University, Coimbra, Portugal
| | - Nuno Almeida
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal.,Medical School, Coimbra University, Coimbra, Portugal
| | - Sofia Mendes
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal
| | - Ana Rita Alves
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal
| | - Ernestina Camacho
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal
| | - Luís Tomé
- Gastroenterology Department, Coimbra Hospital and University Center, Coimbra, Portugal.,Medical School, Coimbra University, Coimbra, Portugal
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18
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Li L, Liu M, Zhang T, Jia Y, Zhang Y, Yuan H, Zhang G, He C. Indomethacin down-regulating HMGB1 and TNF-α to prevent pancreatitis after endoscopic retrograde cholangiopancreatography. Scand J Gastroenterol 2019; 54:793-799. [PMID: 31177924 DOI: 10.1080/00365521.2019.1623306] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
Background and aims: Several articles demonstrated that non-steroidal anti-inflammation drugs (NSAIDs) were effective in reducing the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (PEP). However, studies revealed inconsistent results. The mechanism of NSAIDs in preventing PEP is still little known. Therefore, the aim of our study was to evaluate the efficacy of NSAIDs for PEP prophylaxis and further to explore the mechanism of NSAIDs for prevention of PEP. Methods: Patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) were randomly assigned to receive 100 mg rectal indomethacin or glycerin suppository 15-20 min before ERCP. The primary outcome was the rate of PEP. And the levels of serum HMGB1 and TNF-α were also measured before ERCP and 3 and 24 h after ERCP. Univariate analysis and multivariate analysis were carried out to estimate the independent risk factors for PEP. Results: Totally, 100 patients were enrolled, 50 received indomethacin and 50 with placebo (glycerin suppository). PEP developed in six patients in indomethacin group and 16 in the control group, the difference was significant (p = .016). The levels of HMGB1 and TNF-α were significantly decreased in indomethacin group at 3 (p < .0001) and 24 h (p < .0001) after ERCP, compared to the control group. Multivariate analysis revealed that duration of ERCP (OR, 0.221; 95% CI, 0.072-0.680; p = .008) and usage of NSAIDs (OR, 0.278; 95% CI, 0.090-0.861; p = .026) were independent predictors of PEP. Conclusions: Rectal indomethacin could significantly reduce the risk of PEP by down-regulating the levels of HMGB1 and TNF-α.
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Affiliation(s)
- Lin Li
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Miaomiao Liu
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Tingting Zhang
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Yuliang Jia
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Yan Zhang
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Heming Yuan
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Guozheng Zhang
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
| | - Chiyi He
- Departments of Gastroenterology, Yijishan Hospital of Wannan Medical College , Wuhu , PR China
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Pavel L, Bălan GG, Nicorescu A, Gîlcă-Blanariu GE, Sfarti C, Chiriac Ș, Diaconescu S, Drug VL, Bălan G, Ștefănescu G. Split-dose or hybrid nonsteroidal anti-inflammatory drugs and N-acetylcysteine therapy for prevention of post-retrograde cholangiopancreatography pancreatitis. World J Clin Cases 2019; 7:300-310. [PMID: 30746371 PMCID: PMC6369386 DOI: 10.12998/wjcc.v7.i3.300] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2018] [Revised: 12/18/2018] [Accepted: 12/24/2018] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND Despite significant technical and training improvements, the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has not significantly dropped. Although many studies have evaluated the efficacy of various agents, e.g. nonsteroidal anti-inflammatory drugs, octreotide, antioxidants, administered via various dosages, routes (oral, intrarectal or parenteral), and schedules (before or after the procedure), the results have been conflicting.
AIM To evaluate efficacy of three pharmacologic prophylactic methods for prevention of PEP.
METHODS In this prospective, single-center randomized trial, patients who underwent first-time ERCP for choledocholithiasis were randomly assigned to three groups. The first group received 600 mg N-acetylcysteine 15 min prior to ERCP, and per-rectum administration of 50 mg indomethacin both prior to and after completion of the ERCP. The second group was administered only the 50 mg indomethacin per-rectum both prior to and after the ERCP. The third group was administered per-rectum 100 mg indomethacin only after the ERCP, representing the control group given the guideline-recommended regimen. The primary end-point was PEP prevention.
RESULTS Among the total 211 patients evaluated during the study, 186 fulfilled the inclusion criteria and completed the protocol. The percentages of patients who developed PEP in each of the three groups were not significantly different (χ2 = 2.793, P = 0.247). Among the acute PEP cases, for all groups, 14 patients developed mild pancreatitis (77.77%) and 4 moderate. No severe cases of PEP occurred, and in all PEP cases the resolution was favorable. No adverse events related to the medications (digestive hemorrhage, rectal irritation, or allergies) occurred.
CONCLUSION The efficacies of split-dose indomethacin and combined administration (N-acetylcysteine with indomethacin) for preventing PEP were similar to that of the standard regimen.
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Affiliation(s)
- Laura Pavel
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Gheorghe Gh Bălan
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Alexandra Nicorescu
- Endocrinology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | | | - Cătălin Sfarti
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Ștefan Chiriac
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Smaranda Diaconescu
- Department of Mother and Child Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Vasile Liviu Drug
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Gheorghe Bălan
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
| | - Gabriela Ștefănescu
- Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
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Köksal AŞ, Eminler AT, Parlak E. Biliary endoscopic sphincterotomy: Techniques and complications. World J Clin Cases 2018; 6:1073-1086. [PMID: 30613665 PMCID: PMC6306628 DOI: 10.12998/wjcc.v6.i16.1073] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2018] [Revised: 10/20/2018] [Accepted: 11/26/2018] [Indexed: 02/05/2023] Open
Abstract
Biliary endoscopic sphincterotomy (EST) refers to the cutting of the biliary sphincter and intraduodenal segment of the common bile duct following selective cannulation, using a high frequency current applied with a special knife, sphincterotome, inserted into the papilla. EST is either used solely for the treatment of diseases of the papilla of Vater, such as sphincter of Oddi dysfunction or to facilitate subsequent therapeutic biliary interventions, such as stone extraction, stenting, etc. It is a prerequisite for biliary interventions, thus every practitioner who performs endoscopic retrograde cholangiopancreatography needs to know different techniques and the clinical and anatomic parameters related to the efficacy and safety of the procedure. In this manuscript, we will review the indications, contraindications and techniques of biliary EST and the management of its complications.
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Affiliation(s)
- Aydın Şeref Köksal
- Department of Gastroenterology, Sakarya University, School of Medicine, Sakarya 54290, Turkey
| | - Ahmet Tarik Eminler
- Department of Gastroenterology, Sakarya University, School of Medicine, Sakarya 54290, Turkey
| | - Erkan Parlak
- Department of Gastroenterology, Hacettepe University, School of Medicine, Ankara 41000, Turkey
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21
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Czerwonko ME, Pekolj J, Uad P, Mazza O, Sanchez-Claria R, Arbues G, de Santibañes E, de Santibañes M, Palavecino M. Acute Pancreatitis After Laparoscopic Transcystic Common Bile Duct Exploration: An Analysis of Predisposing Factors in 447 Patients. World J Surg 2018; 42:3134-3142. [PMID: 29616319 DOI: 10.1007/s00268-018-4611-0] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
INTRODUCTION In laparoscopic transcystic common bile duct exploration (LTCBDE), the risk of acute pancreatitis (AP) is well recognized. The present study assesses the incidence, risk factors, and clinical impact of AP in patients with choledocholithiasis treated with LTCBDE. METHODS A retrospective database was completed including patients who underwent LTCBDE between 2007 and 2017. Univariate and multivariate analyses were performed by logistic regression. RESULTS After exclusion criteria, 447 patients were identified. There were 70 patients (15.7%) who showed post-procedure hyperamylasemia, including 20 patients (4.5%) who developed post-LTCBDE AP. Of these, 19 were edematous and one was a necrotizing pancreatitis. Patients with post-LTCBDE AP were statistically more likely to have leukocytosis (p < 0.004) and jaundice (p = 0.019) before surgery and longer operative times (OT, p < 0.001); they were less likely to have incidental intraoperative diagnosis (p = 0.031) or to have biliary colic as the reason for surgery (p = 0.031). In the final multivariate model, leukocytosis (p = 0.013) and OT (p < 0.001) remained significant predictors for AP. Mean postoperative hospital stay (HS) was significantly longer in AP group (p < 0.001). CONCLUSION The risk of AP is moderate and should be considered in patients with preoperative leukocytosis and jaundice and exposed to longer OT. AP has a strong impact on postoperative HS.
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Affiliation(s)
- Matias E Czerwonko
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Juan Pekolj
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Pedro Uad
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Oscar Mazza
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Rodrigo Sanchez-Claria
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Guillermo Arbues
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Eduardo de Santibañes
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Martín de Santibañes
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina
| | - Martín Palavecino
- Department of General Surgery, Division of HPB Surgery, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1181ACH, Buenos Aires, Argentina.
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22
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Smeets XJNM, da Costa DW, Fockens P, Mulder CJJ, Timmer R, Kievit W, Zegers M, Bruno MJ, Besselink MGH, Vleggaar FP, van der Hulst RWM, Poen AC, Heine GDN, Venneman NG, Kolkman JJ, Baak LC, Römkens TEH, van Dijk SM, Hallensleben NDL, van de Vrie W, Seerden TCJ, Tan ACITL, Voorburg AMCJ, Poley JW, Witteman BJ, Bhalla A, Hadithi M, Thijs WJ, Schwartz MP, Vrolijk JM, Verdonk RC, van Delft F, Keulemans Y, van Goor H, Drenth JPH, van Geenen EJM. Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial. Trials 2018; 19:207. [PMID: 29606135 PMCID: PMC5879873 DOI: 10.1186/s13063-018-2583-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2018] [Accepted: 03/06/2018] [Indexed: 12/19/2022] Open
Abstract
Background Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. Methods The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer’s solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. Discussion The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. Trial registration EudraCT: 2015-000829-37. Registered on 18 February 2015. ISRCTN: 13659155. Registered on 18 May 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2583-x) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Xavier J N M Smeets
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands.
| | - David W da Costa
- Department of Radiology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands
| | - Paul Fockens
- Department of Gastroenterology and Hepatology, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands
| | - Chris J J Mulder
- Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands
| | - Robin Timmer
- Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands
| | - Wietske Kievit
- Department of Health Evidence, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands
| | - Marieke Zegers
- Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands
| | - Marco J Bruno
- Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands
| | - Marc G H Besselink
- Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands
| | - Frank P Vleggaar
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, PO 85500, 3508 GA, Utrecht, The Netherlands
| | - Rene W M van der Hulst
- Department of Gastroenterology and Hepatology, Spaarne Gasthuis, PO 417, 2000 AK, Haarlem, The Netherlands
| | - Alexander C Poen
- Department of Gastroenterology and Hepatology, Isala Klinieken, PO 10400, 8000 GK, Zwolle, The Netherlands
| | - Gerbrand D N Heine
- Department of Gastroenterology and Hepatology, Noord-West Hospital, PO 501, 1800 AM, Alkmaar, The Netherlands
| | - Niels G Venneman
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands
| | - Jeroen J Kolkman
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500 KA, Enschede, The Netherlands
| | - Lubbertus C Baak
- Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Postbus 95500, 1090 HM, Amsterdam, The Netherlands
| | - Tessa E H Römkens
- Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, PO 90153, 5200 ME, s'Hertogenbosch, The Netherlands
| | - Sven M van Dijk
- Department of Surgery, Academic Medical Centre, PO 22660, 1100 DD, Amsterdam, The Netherlands
| | - Nora D L Hallensleben
- Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands
| | - Wim van de Vrie
- Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, PO 444, 3300 AK, Dordrecht, The Netherlands
| | - Tom C J Seerden
- Department of Gastroenterology and Hepatology, Amphia Hospital, PO 90158, 4800 RK, Breda, The Netherlands
| | - Adriaan C I T L Tan
- Department of Gastroenterology and Hepatology, Canisius-Wilhelmina Hospital, PO 9015, 6500 GS, Nijmegen, The Netherlands
| | - Annet M C J Voorburg
- Department of Gastroenterology and Hepatology, Diakonessenhuis, PO 80250, 3508 TG, Utrecht, The Netherlands
| | - Jan-Werner Poley
- Department of Gastroenterology and Hepatology, Erasmus Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands
| | - Ben J Witteman
- Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, PO 9025, 6710 HN, Ede, The Netherlands
| | - Abha Bhalla
- Department of Gastroenterology and Hepatology, HAGA Hospital, PO 40551, 2504 LN, The Hague, The Netherlands
| | - Muhammed Hadithi
- Department of Gastroenterology and Hepatology, Maasstad Hospital, PO 9100, 3007 AC, Rotterdam, The Netherlands
| | - Willem J Thijs
- Department of Gastroenterology and Hepatology, Martini Hospital, PO 30033, 9700 RM, Groningen, The Netherlands
| | - Matthijs P Schwartz
- Department of Gastroenterology and Hepatology, Meander Medical Centre, PO 1502, 3800 BM, Amersfoort, The Netherlands
| | - Jan Maarten Vrolijk
- Department of Gastroenterology and Hepatology, Rijnstate Hospital, PO 9555, 6800 TA, Arnhem, The Netherlands
| | - Robert C Verdonk
- Department of Gastroenterology and Hepatology, St Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands
| | - Foke van Delft
- Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam, PO Box 7057, 1007 MB, Amsterdam, The Netherlands
| | - Yolande Keulemans
- Department of Gastroenterology and Hepatology, Zuyderland, PO 5500, 6130 MB, Sittard-Geleen, The Netherlands
| | - Harry van Goor
- Department of Surgery, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands
| | - Joost P H Drenth
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands
| | - Erwin J M van Geenen
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO 9101, 6500 HB, Nijmegen, The Netherlands
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Yaghoobi M, Alzahrani MA, McNabb-Baltar J, Martel M, Barkun AN. Rectal Indomethacin Prevents Moderate to Severe Post-ERCP Pancreatitis and Death and Should Be Used Before the Procedure: A Meta-Analysis of Aggregate Subgroup Data. J Can Assoc Gastroenterol 2018; 1:67-75. [PMID: 31294402 PMCID: PMC6487993 DOI: 10.1093/jcag/gwy006] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
Background Despite overall evidence in the literature favoring rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), its role in preventing potentially fatal complications is not well explored. Method A comprehensive electronic literature search was done to select randomized controlled trials (RCTs) comparing rectal indomethacin and placebo in preventing PEP. Methodological quality was assessed using the Cochrane risk of bias tool. Statistical heterogeneity was characterized. Random effect model meta-analysis was used. Several subgroup, sensitivity and aggregate subgroup data analyses were completed based on specific risk factors or patient characteristics to identify patient populations who may benefit most from rectal indomethacin. Results A total of eight out of 336 trials published between 2007 and 2016 (n=3324) were included. Analysis showed administering rectal indomethacin before rather than during or after ERCP significantly reduced PEP rates (odds ratio (OR): 0.56 [0.40-079]). Rectal indomethacin also significantly decreased the rate of moderate to severe PEP and death amongst all patients (OR: 0.53 [0.31-0.89] and 0.10 [0.02-0.65], respectively). Rectal indomethacin significantly prevented PEP in patients with sphincter of Oddi dysfunction (SOD) (OR: 0.49 [0.30-0.78]) and those undergoing biliary sphincterotomy (OR: 0.63 [0.42-0.95]), but not in those undergoing precut or pancreatic sphincterotomy or prophylactic pancreatic stent placement. Sensitivity analysis showed that the effect remained significant after two studies with high risk of bias were excluded. Conclusion Rectal indomethacin significantly decreases the occurrence of moderate to severe PEP and death in all patients, only if given before the procedure.
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Affiliation(s)
- Mohammad Yaghoobi
- Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.,Cochrane Upper GI and Pancreatic Group, Hamilton, ON, Canada
| | | | - Julia McNabb-Baltar
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Myriam Martel
- Division of Gastroenterology, McGill University Health Sciences, Montreal QC, Canada
| | - Alan N Barkun
- Cochrane Upper GI and Pancreatic Group, Hamilton, ON, Canada.,Division of Gastroenterology, McGill University Health Sciences, Montreal QC, Canada
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Ryozawa S, Itoi T, Katanuma A, Okabe Y, Kato H, Horaguchi J, Fujita N, Yasuda K, Tsuyuguchi T, Fujimoto K. Japan Gastroenterological Endoscopy Society guidelines for endoscopic sphincterotomy. Dig Endosc 2018; 30:149-173. [PMID: 29247546 DOI: 10.1111/den.13001] [Citation(s) in RCA: 56] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/23/2017] [Accepted: 12/10/2017] [Indexed: 02/06/2023]
Abstract
The Japan Gastroenterological Endoscopy Society (JGES) has recently compiled guidelines for endoscopic sphincterotomy (EST) using evidence-based methods. Content regarding actual clinical practice, including detailed endoscopic procedures, instruments, device types and usage, has already been published by the JGES postgraduate education committee in May 2015 and, thus, in these guidelines we avoided duplicating such content as much as possible. The guidelines do not address pancreatic sphincterotomy, endoscopic papillary balloon dilation (EPBD), and endoscopic papillary large balloon dilation (EPLBD). The guidelines for EPLBD are planned to be developed separately. The evidence level in this field is often low and, in many instances, strong recommendation has to be determined on the basis of expert consensus. At this point in time, the guidelines are divided into six items including indications, techniques, specific cases, adverse events, outcomes, and postoperative follow up.
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Affiliation(s)
- Shomei Ryozawa
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Takao Itoi
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Akio Katanuma
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Hironari Kato
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Jun Horaguchi
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Naotaka Fujita
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Kenjiro Yasuda
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
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25
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Garg R, Mohan BP, Krishnamoorthi R, Rustagi T. Pre-endoscopic retrograde cholangiopancreatography (ERCP) administration of rectal indomethacin in unselected patients to reduce post-ERCP pancreatitis: A systematic review and meta-analysis. Indian J Gastroenterol 2018; 37:120-126. [PMID: 29619673 DOI: 10.1007/s12664-018-0841-1] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2017] [Accepted: 03/02/2018] [Indexed: 02/04/2023]
Abstract
INTRODUCTION Previous studies have reported that peri-procedural administration of rectal indomethacin reduces the risk of pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Based on these studies, gastrointestinal (GI) societies recommend prophylactic rectal indomethacin for all patients undergoing ERCP. However, recent studies have reported contradictory results. The aim of this study was to perform a systematic review and meta-analysis to estimate the pooled relative risk (RR) of post-ERCP pancreatitis (PEP) in unselected patients who received rectal indomethacin before the ERCP (pre-ERCP) compared to patients who received pre-ERCP rectal placebo. METHODS We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through September 1, 2017) to identify randomized control trials (RCTs) investigating the role of pre-ERCP rectal indomethacin in reducing the risk of PEP in unselected patients undergoing ERCP. The databases included Ovid, Medline, In-Process, and Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science. We calculated a pooled estimate of the RR of PEP in patients who received pre-ERCP rectal indomethacin compared to patients who received pre-ERCP rectal placebo. The meta-analysis was performed using the random effects model. RESULTS Six RCTs with a total of 2229 patients were included in the final meta-analysis. There were 1143 patients in the rectal indomethacin group and 1086 patients in the rectal placebo group. There were 71 events of PEP in the rectal indomethacin group and 114 events of PEP in the rectal placebo group. Pre-ERCP administration of rectal indomethacin significantly reduced the risk of PEP compared to pre-ERCP rectal placebo (RR 0.60, 95% CI, 0.45-0.80; p<0.0001). There was no heterogeneity between the studies (I2 = 0). CONCLUSION The results of this meta-analysis support the routine pre-ERCP administration of rectal indomethacin in unselected patients to prevent PEP.
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Affiliation(s)
- Rajat Garg
- Department of Internal Medicine, St. John Hospital and Medical Center, Detroit, MI, USA
| | - Babu P Mohan
- Department of Internal Medicine, University of Alabama, Tuscaloosa, AL, USA
| | - Rajesh Krishnamoorthi
- Department of Gastroenterology and Hepatology, Virginia Mason Medical Center, Seattle, WA, USA
| | - Tarun Rustagi
- Division of Gastroenterology and Hepatology, University of New Mexico, MSC10 5550, 1 University of New Mexico, Albuquerque, NM, 87131, USA.
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26
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Sheiybani G, Brydon P, Toolan M, Linehan J, Farrant M, Colleypriest B. Does rectal diclofenac reduce post-ERCP pancreatitis? A district general hospital experience. Frontline Gastroenterol 2018; 9:73-77. [PMID: 29484164 PMCID: PMC5824769 DOI: 10.1136/flgastro-2017-100832] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/03/2017] [Revised: 06/08/2017] [Accepted: 07/03/2017] [Indexed: 02/04/2023] Open
Abstract
INTRODUCTION There is controversy in the literature recently regarding the efficacy of rectal non-steroidal anti-inflammatory drugs (NSAID) to prevent post-ERCP pancreatitis (PEP). The aim of this study was to compare the incidence of PEP in three distinct groups of patients at the Royal United Hospital, Bath: no use of rectal diclofenac, selective use and blanket use without contraindication. METHOD Readmission data, blood results, radiology reports and discharge summaries were used to identify patients with PEP from August 2010 to December 2015. The administration of rectal diclofenac postprocedure was recorded from the endoscopy reporting system. RESULTS 1318 endoscopic retrograde cholangiopancreatographies (ERCP) were performed by four endoscopists during the study period with 66 (5.0%) cases of pancreatitis. 445 ERCPs were performed prior to the introduction of NSAID use during which time, with an incidence of 35 (7.9%) episodes of PEP. During the selective period of NSAID use (high-risk patients) 539 ERCPs were performed and 72 (13.4%) patients received NSAIDs. 17 (3.2%) developed PEP. 334 ERCPs were performed when NSAIDs were given to all patients without contraindication. 289 (86.5%) of patients received rectal diclofenac and 13 (3.9%) developed pancreatitis. There is a statistically significant decrease in PEP comparing the groups of patients receiving NSAIDs selectively (p=0.0009) or routinely (p=0.0172) when compared with none. There is no difference between the selective and routine group (p=0.571). CONCLUSION Our data demonstrate that the introduction of a selective or routine use of NSAIDs for PEP in a District General Hospital (DGH) significantly decreases the risk of pancreatitis (risk reduction 43.7%).
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Affiliation(s)
| | - Peter Brydon
- Gastroenterology, Royal United Hospital, Bath, UK
| | | | - John Linehan
- Gastroenterology, Royal United Hospital, Bath, UK
| | - Mark Farrant
- Gastroenterology, Royal United Hospital, Bath, UK
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27
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Comparative effectiveness of aggressive intravenous fluid resuscitation with lactated Ringer's solution and rectal indomethacin therapy in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography: a double blind randomised controlled clinical trial. GASTROENTEROLOGY REVIEW 2017; 12:271-276. [PMID: 29358996 PMCID: PMC5771451 DOI: 10.5114/pg.2017.72102] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/13/2016] [Accepted: 09/27/2016] [Indexed: 12/18/2022]
Abstract
Introduction There is growing evidence indicating the aggressive intravenous fluid resuscitation (IVFR) can decrease the rate of pancreatitis; however, to the best of our knowledge it has not been well studied in a post-endoscopic retrograde cholangiopancreatography (post-ERCP) setting. Aim To compare the effects of aggressive IVFR and rectal indomethacin (RI) in preventing pancreatitis after ERCP. Material and methods This is a double blind randomised controlled clinical trial on 186 patients undergoing ERCP in Ahvaz, Iran. The inclusion criteria were ERCP for standard clinical indications such as choledocholithiasis, bile duct leak, and biliary obstruction. The IVFR group (n = 62) received a bolus of 20 ml/kg of body weight lactated Ringer's solution (LRS) immediately after ERCP, followed by 3 ml/kg/h maintenance for 8 h. The RI group (n = 62) received 50 mg rectal indomethacin immediately before procedure and 12 h after ERCP. The control group (n = 62) did not receive any treatment. Results Post-ERCP pancreatitis in IVFR, rectal indomethacin, and control groups occurred in 8 (12.9%), 16 (25.8%), and 20 (32.3%) patients (p = 0.036). Pancreatic pain was reported in 13 (21%), 21 (33.9%), and 27 (43.5%) patients in the IVFR, RI, and control group (p = 0.046). The serum amylase level increased over 24 h after intervention in all three groups. The mean serum amylase level 8 h after intervention in the IVFR patients was lower than the RI and control groups. Conclusions Intravenous fluid resuscitation with LRS was more effective in preventing post-ERCP pancreatitis in comparison to the rectal indomethacin and control group.
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Miyatani H, Matsumoto S, Mashima H. Risk factors of post- endoscopic retrograde cholangiopancreatography pancreatitis in biliary type sphincter of Oddi dysfunction in Japanese patients. J Dig Dis 2017; 18:591-597. [PMID: 28898571 DOI: 10.1111/1751-2980.12541] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2017] [Revised: 05/14/2017] [Accepted: 09/08/2017] [Indexed: 02/06/2023]
Abstract
OBJECTIVE Suspected sphincter of Oddi dysfunction (SOD) is a well-known risk factor for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The indication of ERCP for suspected SOD patients was very low in Japan compared to other countries. Therefore, the risk of PEP may be different in Japanese SOD patients. The objective of this study was to evaluate the risk of PEP in suspected biliary type SOD in Japan. METHODS From December 1996 to January 2017, 72 patients were suspected as having biliary type SOD, by questionnaire, liver function tests, hepatobiliary scintigraphy, abdominal ultrasonography, upper gastrointestinal endoscopy, endoscopic ultrasonography and magnetic resonance cholangiopancreatography. Finally, 60 patients who underwent ERCP were included in this study, and the factors associated with PEP were evaluated. RESULTS The overall PEP rate was 23.3% (n = 14). Diagnostic ERCP alone for SOD did not increase the risk of PEP. The correlation of PEP incidence with pancreatic duct guidewire (PGW) technique and endoscopic sphincterotomy (EST) was indicated in univariate and multivariate analysis. Pancreatic stent placement was a risk in univariate analysis but not in multivariate analysis. CONCLUSIONS PGW technique and EST for biliary type SOD were important risk factors for PEP. Pancreatic stenting was ineffective for prevention of PEP.
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Affiliation(s)
- Hiroyuki Miyatani
- Department of Gastroenterology, Jichi Medical University, Saitama, Japan
| | - Satohiro Matsumoto
- Department of Gastroenterology, Jichi Medical University, Saitama, Japan
| | - Hirosato Mashima
- Department of Gastroenterology, Jichi Medical University, Saitama, Japan
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Li L, Han Z, Yuan H, Zhang G, Jia Y, He C. Nonsteroidal anti-inflammatory drugs reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis. JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES 2017; 24:520-529. [PMID: 28681997 DOI: 10.1002/jhbp.489] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
BACKGROUND Several recent studies suggested that nonsteroidal anti-inflammation drugs (NSAIDs) could prevent the pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the routes of administration, the dosages of NSAIDs and the potential efficacy in reducing the severity of pancreatitis remain controversial. The aim of this meta-analysis was to evaluate the efficacy of NSAIDs for post-ERCP pancreatitis (PEP) prophylaxis. METHODS We systematically searched PubMed, Embase, EBSCO, Elsevier and Web of Science databases up to 1 October 2016 for relevant studies. RESULTS A total of 24 studies met the inclusion criteria. Compared to the controls, the risk of pancreatitis was much lower in the NSAIDs group (OR = 0.57, 95% CI: 0.48-0.67, P < 0.0001). However, NSAIDs were not effective in reducing the risk of moderate to severe pancreatitis compared with placebo (OR = 0.75, 95% CI: 0.57-1.00). In the subanalyses, rectal administration was the only effective route (OR = 0.51, 95% CI: 0.42-0.62), and the risk of PEP was reduced in both randomized controlled trials (RCTs) (OR = 0.63, 95% CI: 0.52-0.76) and case-control articles (C-Cs) (OR = 0.40, 95% CI: 0.28-0.58). CONCLUSIONS Prophylactic administration of NSAIDs reduced the incidence of PEP in both RCTs and C-Cs, especially when rectally administered, but was not effective in reducing the risk of moderate to severe pancreatitis.
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Affiliation(s)
- Lin Li
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Zhen Han
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Heming Yuan
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Guozheng Zhang
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Yuliang Jia
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Chiyi He
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
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Celecoxib Oral Administration for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Randomized Prospective Trial. Pancreas 2017; 46:880-886. [PMID: 28697127 DOI: 10.1097/mpa.0000000000000852] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Rectal nonsteroidal anti-inflammatory drugs have reported promising prophylactic activity in post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Conversely, cyclooxygenase-2 enzyme has been suggested to contribute to experimental acute pancreatitis. The aim of this study was to evaluate the efficacy of oral administration of celecoxib, a cyclooxygenase-2 inhibitor, for the prevention of PEP. METHODS We performed a prospective randomized controlled study. Patients who were scheduled to undergo ERCP were randomized to receive either oral 400-mg celecoxib tablets 1 hour before ERCP and saline infusion (celecoxib group) or saline infusion only (control group). The primary outcome measure was the frequency of PEP. RESULTS A total of 170 patients were randomized; 85 patients each in the celecoxib group and control group were analyzed. After the procedure, 23 patients (13.5%) developed PEP. There was no difference in the frequency of PEP between the 2 groups (control group vs celecoxib group, 15.3% (13/85) vs 11.7% (10/85); P = 0.65). The severity of PEP, asymptomatic hyperamylasemia, and post-ERCP pain were not significantly different between the 2 groups. There were no adverse events related to celecoxib treatment. CONCLUSIONS Oral administration of celecoxib had no beneficial preventive effect on PEP.
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Rainio M, Lindström O, Udd M, Louhimo J, Kylänpää L. Diclofenac Does Not Reduce the Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in Low-Risk Units. J Gastrointest Surg 2017; 21:1270-1277. [PMID: 28374181 DOI: 10.1007/s11605-017-3412-3] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2017] [Accepted: 03/26/2017] [Indexed: 01/31/2023]
Abstract
BACKGROUND Nonsteroidal anti-inflammatory drugs have an inhibitory role in pathogenesis of pancreatitis. Guidelines from the European Society of Gastrointestinal Endoscopy recommend routine rectal administration of 100 mg of diclofenac or indomethacin immediately before or after ERCP for all patients without contraindications. AIMS Our aim was to evaluate the effect of diclofenac in preventing post-ERCP pancreatitis (PEP) in a high-volume, low-PEP-risk ERCP unit. METHODS The rate and severity of PEP were compared in groups of 1000 historical controls prior to the routine use of diclofenac and in 1000 patients receiving 100 mg diclofenac before ERCP. RESULTS PEP occurred in 56 (2.8%) of the 2000 patients, and the rate of the pancreatitis was 2.8% in control group and 2.8% in diclofenac group (p = 1.000). The PEP rate among the native papilla patients was 3.9% in control group and 3.6% in diclofenac group (p = 0.803). In subgroup analysis of patients with a high risk of PEP, diclofenac neither prevented PEP nor made its course milder. CONCLUSIONS In an unselected patient population in a center with a low incidence of PEP, diclofenac seems to have no beneficial effect.
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Affiliation(s)
- Mia Rainio
- Department of Gastrointestinal Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland.
| | - Outi Lindström
- Department of Gastrointestinal Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland
| | - Marianne Udd
- Department of Gastrointestinal Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland
| | - Johanna Louhimo
- Department of Gastrointestinal Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland
| | - Leena Kylänpää
- Department of Gastrointestinal Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, 00290, Helsinki, Finland
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Patai Á, Solymosi N, Mohácsi L, Patai ÁV. Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials. Gastrointest Endosc 2017; 85:1144-1156.e1. [PMID: 28167118 DOI: 10.1016/j.gie.2017.01.033] [Citation(s) in RCA: 68] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2016] [Accepted: 01/16/2017] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS Diclofenac and indomethacin are the most studied drugs for preventing post-ERCP pancreatitis (PEP). However, there are no prospective, randomized multicenter trials with a sufficient number of patients for correct evaluation of their efficacy. Our aim was to evaluate all prospective trials published in full text that studied the efficacy of diclofenac or indomethacin and were controlled with placebo or non-treatment for the prevention of PEP in adult patients undergoing ERCP. METHODS Systematic search of databases (PubMed, Scopus, Web of Science, Cochrane) for relevant studies published from inception to 30 June 2016. RESULTS Our meta-analysis of 4741 patients from 17 trials showed that diclofenac or indomethacin significantly decreased the risk ratio (RR) of PEP to 0.60 (95% confidence interval [CI], 0.46-0.78; P = .0001), number needed to treat (NNT) was 20, and the reduction of RR of moderate to severe PEP was 0.64 (95% CI, 0.43-0.97; P = .0339). The efficacy of indomethacin compared with diclofenac was similar (P = .98). The efficacy of indomethacin or diclofenac did not differ according to timing (P = .99) or between patients with average-risk and high-risk for PEP (P = .6923). The effect of non-rectal administration of indomethacin or diclofenac was not significant (P = .1507), but the rectal route was very effective (P = .0005) with an NNT of 19. The administration of indomethacin or diclofenac was avoided in patients with renal failure. Substantial adverse events were not detected. CONCLUSIONS The use of rectally administered diclofenac or indomethacin before or closely after ERCP is inexpensive and safe and is recommended in every patient (without renal failure) undergoing ERCP. (Registration number: CRD42016042726, http://www.crd.york.ac.uk/prospero/.).
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Affiliation(s)
- Árpád Patai
- Department of Gastroenterology and Medicine, Markusovszky University Teaching Hospital, Szombathely, Hungary
| | - Norbert Solymosi
- Biometeorology Research Group, University of Veterinary Medicine, Budapest, Hungary
| | - László Mohácsi
- Department of Computer Science, Corvinus University of Budapest, Budapest, Hungary
| | - Árpád V Patai
- 2nd Department of Medicine, Semmelweis University, Budapest, Hungary
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Feng Y, Navaneethan U, Zhu X, Varadarajulu S, Schwartz I, Hawes R, Hasan M, Yang A. Prophylactic rectal indomethacin may be ineffective for preventing post-endoscopic retrograde cholangiopancreatography pancreatitis in general patients: A meta-analysis. Dig Endosc 2017; 29:272-280. [PMID: 27914176 DOI: 10.1111/den.12779] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2016] [Accepted: 11/28/2016] [Indexed: 12/20/2022]
Abstract
BACKGROUND AND AIM Efficacy of prophylactic indomethacin for prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in general patients remains controversial. To address this, we conducted a meta-analysis of clinical trials specifically on rectal indomethacin in prevention of PEP in consecutive patients undergoing ERCP. METHODS We searched MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases to identify randomized, double-blind, controlled clinical trials on rectal indomethacin in the prevention of PEP in consecutive patients undergoing ERCP. Primary outcome was the overall rate of PEP. Secondary outcomes were the overall rates of moderate to severe PEP and mild PEP. RESULTS Six studies, with a total of 2473 patients, were included. Overall rate of PEP was 7% (95% CI, 6-9%). No statistical difference was observed in overall rates of PEP (OR, 0.67; 95% CI, 0.46-1.00, P = 0.050) and, additionally, rates of moderate to severe (OR, 0.66; 95% CI, 0.28-1.56, P = 0.345) or mild (OR, 0.71; 95% CI, 0.45-1.10, P = 0.127) PEP between indomethacin and placebo. CONCLUSION In a contemporary meta-analysis of available randomized controlled trials of consecutive patients undergoing ERCP, rectal indomethacin did not show significant prevention effect of post-ERCP pancreatitis.
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Affiliation(s)
- Yunlu Feng
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA.,Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
| | | | - Xiang Zhu
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | | | - Ingrid Schwartz
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA.,Hospital Sao Lucas, Rio de Janeiro, Brazil
| | - Robert Hawes
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | - Muhammad Hasan
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | - Aiming Yang
- Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
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Shen C, Shi Y, Liang T, Su P. Rectal NSAIDs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in unselected patients: Systematic review and meta-analysis. Dig Endosc 2017; 29:281-290. [PMID: 28112441 DOI: 10.1111/den.12816] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Accepted: 01/18/2017] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIM Efficacy of rectal non-steroidal anti-inflammatory drugs (NSAIDs) for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) prophylaxis in unselected patients remained controversial. The aim of the present study was to evaluate the efficacy of rectal NSAIDs in the prevention of PEP in unselected patients. METHODS An electronic literature search in the Cochrane Library, Embase, and PubMed was carried out for randomized controlled trials comparing rectal indomethacin or diclofenac with placebo in the prevention of PEP in unselected patients. Cochrane risk of bias tool was used to evaluate methodological quality. The data were carried out in forest plots using fixed-effect methods, and random-effect methods were used when heterogeneity was significant. RESULTS A total of nine trials were included in our final analysis. Rectal NSAIDs were effective to reduce the incidence of PEP in unselected patients (RR, 0.61; 95% CI, 0.46-0.79), especially for moderate-to-severe PEP (RR, 0.37; 95% CI, 0.17-0.79). Both indomethacin (RR, 0.67; 95% CI, 0.50-0.88) and diclofenac (RR, 0.29; 95% CI, 0.12-0.69) were significantly efficacious. Rectal NSAIDs given pre-ERCP showed significant efficacy (RR, 0.53; 95% CI, 0.39-0.71), whether when given within 30 min pre-ERCP (RR, 0.62; 95% CI, 0.42-0.92) or not (RR, 0.43; 95% CI, 0.28-0.67). CONCLUSION Rectal NSAIDs are effective in the prevention of PEP in unselected patients.
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Affiliation(s)
- Chongrong Shen
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Yanqiang Shi
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Tianyu Liang
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Peizhu Su
- Department of Gastroenterology, First People's Hospital of Foshan Affiliated to Sun Yat-sen University, Foshan City, China
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Hou YC, Hu Q, Huang J, Fang JY, Xiong H. Efficacy and safety of rectal nonsteroidal anti-inflammatory drugs for prophylaxis against post-ERCP pancreatitis: a systematic review and meta-analysis. Sci Rep 2017; 7:46650. [PMID: 28440297 PMCID: PMC5404221 DOI: 10.1038/srep46650] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Accepted: 03/24/2017] [Indexed: 12/16/2022] Open
Abstract
Rectal nonsteroidal anti-inflammatory drugs (NSAIDs) are not commonly used clinically for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. To evaluate the efficacy and safety of NSAIDs for post-ERCP prophylaxis, we systematically reviewed sixteen randomized controlled trials (involving 6458 patients) that compared rectal NSAIDs with placebo or no treatment for post-ERCP pancreatitis prophylaxis updated to August 2016. GRADE framework was used to assess the quality of evidence. There was “high quality” evidence that rectal NSAIDs were associated with significant reduction in the risk of overall post-ERCP pancreatitis (RR, 0.55; 95% CI, 0.42–0.71). Subgroup analyses demonstrated that diclofenac (RR, 0.41; 95% CI, 0.19–0.90) was probably superior to indomethacin (RR, 0.58; 95% CI, 0.45–0.75), post-ERCP administration (RR, 0.46; 95% CI, 0.24–0.89) was probably superior to pre-ERCP (RR, 0.53; 95% CI, 0.42–0.67), and that mixed-risk population received more benefits (RR, 0.54; 95% CI, 0.33–0.88) than average-risk population (RR, 0.60; 95% CI, 0.41–0.88), but less than high-risk population (RR, 0.41; 95% CI, 0.19–0.91). Moreover, “high quality” evidence showed that rectal NSAIDs were safe when given as a standard dose (RR = 0.80; 95% CI, 0.47–1.36). In conclusion, this meta-analysis revealed that rectal NSAIDs are effective and safe in the prevention of post-ERCP pancreatitis in populations with all levels of risk.
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Affiliation(s)
- Yi-Chao Hou
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Qiang Hu
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Jiao Huang
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Jing-Yuan Fang
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Hua Xiong
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
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Tarnasky PR, Kedia P. Endoscopic retrograde cholangiopancreatography complications: Techniques to reduce risk and management strategies. GASTROINTESTINAL INTERVENTION 2017. [DOI: 10.18528/gii170004] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Affiliation(s)
- Paul R. Tarnasky
- Methodist Dallas Medical Center, Methodist Digestive Institute, Dallas, TX, USA
| | - Prashant Kedia
- Methodist Dallas Medical Center, Methodist Digestive Institute, Dallas, TX, USA
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Inamdar S, Han D, Passi M, Sejpal DV, Trindade AJ. Rectal indomethacin is protective against post-ERCP pancreatitis in high-risk patients but not average-risk patients: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85:67-75. [PMID: 27612923 DOI: 10.1016/j.gie.2016.08.034] [Citation(s) in RCA: 49] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2016] [Accepted: 08/23/2016] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Rectal indomethacin is a popular chemopreventive agent to help prevent post-ERCP pancreatitis (PEP). Previous meta-analyses have shown an overall protective effect for PEP in average-risk and high-risk patients. However, these meta-analyses are limited by a small number of studies. Recently, more trials have been published addressing this issue. The aim is to determine whether rectal indomethacin prevents PEP in average-risk and high-risk groups, after incorporating these new data. METHODS A comprehensive search of multiple literature databases in April 2016 was performed. Human prospective randomized controlled trials with placebo controls that examined the effect of rectally administered indomethacin on the incidence of PEP were included. RESULTS A total of 8 trials between 2007 and 2016 (n = 3778) were included. No significant publication bias existed. All studies used similar criteria to detect pancreatitis. Random effects model meta-analysis showed that the rate of PEP was significantly lower using indomethacin compared with placebo (relative risk, 0.43; 95% confidence interval, 0.28-0.65; P < .001) in high-risk patients. There was no significant statistical or clinical heterogeneity. Among average-risk patients, the rate of PEP was similar (non-significant) between the indomethacin and placebo groups (relative risk, 0.74; 95% confidence interval, 0.52-1.07; P = .115). The result of the main outcome remained robust in multiple sensitivity analyses. CONCLUSIONS Rectal indomethacin given before or after ERCP is protective against PEP in high-risk patients versus placebo; however, it is not protective in average-risk patients versus placebo.
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Affiliation(s)
- Sumant Inamdar
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Dennis Han
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Monica Passi
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Divyesh V Sejpal
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Arvind J Trindade
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
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Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85:32-47. [PMID: 27546389 DOI: 10.1016/j.gie.2016.06.051] [Citation(s) in RCA: 521] [Impact Index Per Article: 65.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2016] [Accepted: 06/30/2016] [Indexed: 02/07/2023]
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Endoscopic and pharmacological treatment for prophylaxis against postendoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis and systematic review. Eur J Gastroenterol Hepatol 2016; 28:1415-1424. [PMID: 27580214 DOI: 10.1097/meg.0000000000000734] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND AND AIM Postendoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis (PEP) is the most common complication following ERCP. We carried out a systematic review and meta-analysis of the global literature on PEP prevention to provide clinical guidance and a framework for future research in this important field. METHODS PubMed, Embase, Science Citation Index, Ovid, and the Cochrane Controlled Trials Register were searched by two independent reviewers to identify full-length, prospective, randomized controlled trials (RCTs) published up until March 2016 investigating the use of pancreatic duct stents and pharmacological agents to prevent PEP. RESULTS Twelve RCTs comparing the risk of PEP after pancreatic duct stent placement (1369 patients) and 30 RCTs comparing pharmacological agents over placebo (10251 patients) fulfilled the inclusion criteria and were selected for final review and analysis. Meta-analysis showed that prophylactic pancreatic stents significantly decreased the odds of post-ERCP pancreatitis [odds ratio (OR), 0.28; 95% confidence interval (CI), 0.18-0.42]. Significant OR reduction of PEP was also observed in relation to rectal administration of diclofenac (OR, 0.24; 95% CI, 0.12-0.48) and rectal administration of indometacin (OR, 0.59; 95% CI, 0.44-0.79) compared with placebo. Subgroup analysis showed a significant reduction with bolus-administered somatostatin (OR, 0.23; 95% CI, 0.11-0.49). Subgroup analysis showed a significant reduction with bolus-administered somatostatin (OR, 0.23; 95% CI, 0.11-0.49). CONCLUSION Pancreatic stent placement, rectal diclofenac, and bolus administration of somatostatin appear to be most effective in preventing post-ERCP pancreatitis.
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Ishiwatari H, Urata T, Yasuda I, Matsusaki S, Hisai H, Kawakami H, Ono M, Iwashita T, Doi S, Kawakubo K, Hayashi T, Sonoda T, Sakamoto N, Kato J. No Benefit of Oral Diclofenac on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Dig Dis Sci 2016; 61:3292-3301. [PMID: 27447477 DOI: 10.1007/s10620-016-4251-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2016] [Accepted: 07/09/2016] [Indexed: 12/15/2022]
Abstract
BACKGROUND Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries. AIMS We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial. METHODS Patients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase). RESULTS We initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP. CONCLUSIONS Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO UMIN000008109.
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Affiliation(s)
- Hirotoshi Ishiwatari
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
| | - Takahiro Urata
- Department of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan
| | - Ichiro Yasuda
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan
| | - Shimpei Matsusaki
- Department of Gastroenterology, Suzuka General Hospital, 53-1275, Uyamanohana, Yasuzukacho, Suzuka, Mie, 513-8630, Japan
| | - Hiroyuki Hisai
- Department of Gastroenterology, Japanese Red Cross Date Hospital, 81, Suenagacho, Date, Hokkaido, 052-8511, Japan
| | - Hiroshi Kawakami
- Department of Gastroenterology and Hepatology, Center for Digestive Disease, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, 889-1692, Japan
| | - Michihiro Ono
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Takuji Iwashita
- First Department of Internal Medicine, Gifu University Hospital, 1-1, Yanagito, Gifu, Gifu, 501-1194, Japan
| | - Shinpei Doi
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan
| | - Kazumichi Kawakubo
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan
| | - Tsuyoshi Hayashi
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Tomoko Sonoda
- Department of Public Health, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Naoya Sakamoto
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan
| | - Junji Kato
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
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Wang AY, Strand DS, Shami VM. Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: Medications and Techniques. Clin Gastroenterol Hepatol 2016; 14:1521-1532.e3. [PMID: 27237430 DOI: 10.1016/j.cgh.2016.05.026] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/02/2014] [Revised: 05/17/2016] [Accepted: 05/18/2016] [Indexed: 02/07/2023]
Abstract
Over the past 2 decades, it increasingly has been recognized that endoscopic retrograde cholangiopancreatography (ERCP) is the most predictable provocateur of acute pancreatitis, with an incidence of more than 15% in high-risk patients. For this reason, there has been considerable interest in the effect of periprocedural drug administration as well as different ERCP techniques on both the incidence and severity of post-ERCP pancreatitis. Although many agents and techniques have shown promise in small clinical studies, the majority of these have failed to yield consistent benefit in larger randomized patient groups. This review summarizes the data on medications and ERCP techniques that have been studied for the prevention of post-ERCP pancreatitis.
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Affiliation(s)
- Andrew Y Wang
- Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, Virginia.
| | - Daniel S Strand
- Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, Virginia
| | - Vanessa M Shami
- Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, Virginia
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Prophylaxis of pancreatitis with intravenous ketoprofen in a consecutive population of ERCP patients: a randomized double-blind placebo-controlled trial. Surg Endosc 2016; 31:2317-2324. [PMID: 27651353 DOI: 10.1007/s00464-016-5234-x] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2016] [Accepted: 08/30/2016] [Indexed: 12/18/2022]
Abstract
Background Acute pancreatitis is the most common complication after ERCP, occurring in about 4 % of the procedures. Only the placement of pancreatic duct prosthesis and the use of nonsteroidal anti-inflammatory drugs (NSAIDs) have shown benefit in the prevention of post-ERCP pancreatitis (PEP). Although the benefit of rectal administration of indomethacin or diclofenac is recommended by some studies and society guidelines especially in a selected group of high-risk patients, there is so far, no standardization of time or route of NSAID administration. The aim of the current study is to investigate the role of an intravenous NSAID administered before the procedure for PEP prevention. Methods In this randomized double-blind clinical trial, all consecutive patients who underwent ERCP were randomized to receive saline infusion with ketoprofen or saline, immediately before the procedure. Results A total of 477 patients were enrolled and completed follow-up. The majority of patients (72.1 %) had bile duct stones, and only 1.5 % had a clinical suspicion of sphincter of Oddi dysfunction. PEP developed in 5 of 253 (2 %) patients in the placebo group and in 5 of 224 (2.2 %) patients in the ketoprofen group (p = 1.). Conclusions Intravenous administration of ketoprofen immediately prior to ERCP did not result in reduction in PEP in a general population of ERCP patients.
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Smeets XJNM, da Costa DW, Besselink MG, Bruno MJ, Fockens P, Mulder CJJ, van der Hulst RW, Vleggaar FP, Timmer R, Drenth JPH, van Geenen EJM. Systematic review: periprocedural hydration in the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther 2016; 44:541-53. [PMID: 27444408 DOI: 10.1111/apt.13744] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2016] [Revised: 06/06/2016] [Accepted: 07/06/2016] [Indexed: 02/07/2023]
Abstract
BACKGROUND With an overall incidence of 3.5%, pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Periprocedural hydration may prevent post-ERCP pancreatitis by maintaining pancreatic microperfusion, thereby inhibiting the pancreatic inflammatory response. However, the evidence for periprocedural hydration as a preventive measure is unclear. AIM To conduct a systematic review to assess the evidence regarding periprocedural hydration as a preventive measure for post-ERCP pancreatitis. METHODS We searched PubMed and EMBASE databases and adhered to the PRISMA guidelines. We included studies addressing periprocedural hydration as a preventive measure to reduce frequency and severity of post-ERCP pancreatitis. Study quality was assessed by using the MINORS and Cochrane Collaboration's tool. RESULTS Six studies with a total of 1102 patients were included. Two randomised controlled trials reported a decreased incidence of post-ERCP pancreatitis after hydration: 0% vs. 17% (P = 0.016) and 5.3% vs. 22.7% (P = 0.002). A third trial and two case-controls studies did not report significant differences. Two retrospective studies found that patients with mild post-ERCP pancreatitis had received significantly more fluids during (mean 940 mL vs. 810 mL; P = 0.031) or after ERCP (median 2834 mL vs. 2044 mL; P < 0.02) compared to patients with moderate/severe disease. Adverse events of periprocedural hydration were not reported in any of the included studies. The different methodologies of the included studies precluded a formal data synthesis. CONCLUSIONS There is some evidence to suggest that hydration affords protection against post-ERCP pancreatitis, but study heterogeneity precludes firm conclusions. Adequately powered randomised trials are needed to evaluate the preventive effect of periprocedural hydration.
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Affiliation(s)
- X J N M Smeets
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands
| | - D W da Costa
- Department of Radiology, St. Antonius Hospital, Nieuwegein, Utrecht, The Netherlands
| | - M G Besselink
- Department of Surgery, Academic Medical Center, Amsterdam, Noord-Holland, The Netherlands
| | - M J Bruno
- Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands
| | - P Fockens
- Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, Noord-Holland, The Netherlands
| | - C J J Mulder
- Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, Noord-Holland, The Netherlands
| | - R W van der Hulst
- Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Haarlem, Noord-Holland, The Netherlands
| | - F P Vleggaar
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
| | - R Timmer
- Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, Utrecht, The Netherlands
| | - J P H Drenth
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands
| | - E J M van Geenen
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands
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Adler DG. Rectal Nonsteroidal Anti-inflammatory Drugs to Reduce the Rate and Severity of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: Still Grappling With Fundamental Questions. Gastroenterology 2016; 151:225-7. [PMID: 27371878 DOI: 10.1053/j.gastro.2016.06.030] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Affiliation(s)
- Douglas G Adler
- University of Utah School of Medicine, Gastroenterology and Hepatology, Salt Lake City, Utah.
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Management of acute pancreatitis (AP) - Polish Pancreatic Club recommendations. GASTROENTEROLOGY REVIEW 2016; 11:65-72. [PMID: 27350832 PMCID: PMC4916242 DOI: 10.5114/pg.2016.60251] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 05/15/2016] [Accepted: 05/22/2016] [Indexed: 12/16/2022]
Abstract
The presented recommendations concern the current management of acute pancreatitis. The recommendations relate to the diagnostics and treatment of early and late phases of acute pancreatitis and complications of the disease taking into consideration surgical and endoscopic methods. All the recommendations were subjected to voting by the members of the Working Group of the Polish Pancreatic Club, who evaluated them every single time on a five-point scale, where A means full acceptance, B means acceptance with a certain reservation, C means acceptance with a serious reservation, D means rejection with a certain reservation and E means full rejection. The results of the vote, together with commentary, are provided for each recommendation.
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Mansour-Ghanaei F, Joukar F, Taherzadeh Z, Sokhanvar H, Hasandokht T. Suppository naproxen reduces incidence and severity of post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial. World J Gastroenterol 2016; 22:5114-5121. [PMID: 27275104 PMCID: PMC4886387 DOI: 10.3748/wjg.v22.i21.5114] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/25/2015] [Revised: 10/27/2015] [Accepted: 01/17/2016] [Indexed: 02/06/2023] Open
Abstract
AIM To determine the efficacy of rectally administered naproxen for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS This double-blind randomized control trial conducted from January 2013 to April 2014 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 324 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method. Patients received a single dose of Naproxen (500 mg; n = 162) or a placebo (n = 162) per rectum immediately before ERCP. The overall incidence of PEP, incidence of mild to severe PEP, serum amylase levels and adverse effects were measured. The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and elevation of the serum amylase level to > 3 × the upper normal limit (60-100 IU/L) within 24 h after ERCP. The severity of PEP was classified according to the duration of therapeutic intervention for PEP: mild, 2-3 d; moderate 4-10 d; and severe, > 10 d and/or necessitated surgical or intensive treatment, or contributed to death. RESULTS PEP occurred in 12% (40/324) of participants, and was significantly more frequent in the placebo group compared to the naproxen group (P < 0.01). Of the participants, 25.9% (84/324) developed hyperamylasemia within 2 h of procedure completion, among whom only 35 cases belonged to the naproxen group (P < 0.01). The incidence of PEP was significantly higher in female sex, in patients receiving pancreatic duct injection, more than 3 times pancreatic duct cannulations, and ERCP duration more than 40 min (Ps < 0.01). There were no statistically significant differences between the groups regarding the procedures or factors that might increase the risk of PEP, sphincterotomy, precut requirement, biliary duct injection and number of pancreatic duct cannulations. In the subgroup of patients with pancreatic duct injection, the rate of pancreatitis in the naproxen group was significantly lower than that in the placebo (6 patients vs 23 patients, P < 0.01, RRR = 12%, AR = 0.3, 95%CI: 0.2-0.6). Naproxen reduced the PEP in patients with ≥ 3 pancreatic cannulations (P < 0.01, RRR = 25%, AR = 0.1, 95%CI: 0.1-0.4) and an ERCP duration > 40 min (P < 0.01, RRR = 20%, AR = 0.9, 95%CI: 0.4-1.2). CONCLUSION Single dose of suppository naproxen administered immediately before ERCP reduces the incidence of PEP.
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Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet 2016; 387:2293-2301. [PMID: 27133971 DOI: 10.1016/s0140-6736(16)30310-5] [Citation(s) in RCA: 132] [Impact Index Per Article: 14.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis. METHODS We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650. FINDINGS Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34-0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]). INTERPRETATION Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP. FUNDING National Key Technology R&D Program, National Natural Science Foundation of China.
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Affiliation(s)
- Hui Luo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Lina Zhao
- Department of Radiotherapy, Xijing Hospital, Fourth Military Medical University, Xi'an, China
| | - Joseph Leung
- Gastroenterology, Sacramento VA Medical Center, VANCHCS, Mather, and UC Davis Medical Center, Sacramento, CA, USA
| | - Rongchun Zhang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Zhiguo Liu
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Xiangping Wang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Biaoluo Wang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Zhanguo Nie
- Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China
| | - Ting Lei
- Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China
| | - Xun Li
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Wence Zhou
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Lingen Zhang
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Qi Wang
- Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China
| | - Ming Li
- Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China
| | - Yi Zhou
- Department of Gastroenterology, No 451 Military Hospital, Xi'an, China
| | - Qian Liu
- Department of Gastroenterology, No 451 Military Hospital, Xi'an, China
| | - Hao Sun
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
| | - Zheng Wang
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
| | - Shuhui Liang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Xiaoyang Guo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Qin Tao
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Kaichun Wu
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Yanglin Pan
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
| | - Xuegang Guo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
| | - Daiming Fan
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
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Mukai S, Itoi T. Selective biliary cannulation techniques for endoscopic retrograde cholangiopancreatography procedures and prevention of post- endoscopic retrograde cholangiopancreatography pancreatitis. Expert Rev Gastroenterol Hepatol 2016; 10:709-22. [PMID: 26782710 DOI: 10.1586/17474124.2016.1143774] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Numerous endoscopic retrograde cholangiopancreatography (ERCP) techniques have been reported to achieve selective biliary cannulation success. For standard biliary cannulation procedures, the wire-guided cannulation technique has been reported to reduce the rate of post-ERCP pancreatitis (PEP) and increase the biliary cannulation success rate, although conflicting reports exist. The pancreatic or double-guidewire technique and several precut techniques have been reported as useful techniques in difficult biliary cannulation cases. Although ERCP is a useful endoscopic procedure, the risk of adverse events, particularly post-ERCP pancreatitis, is inevitable. Previous studies and analyses have revealed the risk factors for PEP. The efficacy of prophylactic pancreatic duct stent placement and the administration of rectal nonsteroidal anti-inflammatory drugs for preventing PEP has also been reported. Herein, we reviewed reports in the literature regarding the current status of selective biliary cannulation techniques and PEP prevention.
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Affiliation(s)
- Shuntaro Mukai
- a Department of Gastroenterology and Hepatology , Tokyo Medical University , Tokyo , Japan
| | - Takao Itoi
- a Department of Gastroenterology and Hepatology , Tokyo Medical University , Tokyo , Japan
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Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology 2016; 150:911-7; quiz e19. [PMID: 26775631 PMCID: PMC4808426 DOI: 10.1053/j.gastro.2015.12.040] [Citation(s) in RCA: 141] [Impact Index Per Article: 15.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2015] [Revised: 12/23/2015] [Accepted: 12/27/2015] [Indexed: 12/21/2022]
Abstract
BACKGROUND & AIMS Rectal indomethacin, a nonsteroidal anti-inflammatory drug, is given to prevent pancreatitis in high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), based on findings from clinical trials. The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP, including those at average risk for pancreatitis. We performed a randomized controlled trail to investigate the efficacy of this approach. METHODS We performed a prospective, double-blind, placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center, from March 2013 through December 2014. Approximately 70% of the cohort were at average risk for PEP. Subjects were assigned randomly to groups given either a single 100-mg dose of rectal indomethacin (n = 223) or a placebo suppository (n = 226) during the procedure. The primary outcome was the development of post-ERCP pancreatitis (PEP), defined by new upper-abdominal pain, a lipase level more than 3-fold the upper limit of normal, and hospitalization after ERCP for 2 consecutive nights. RESULTS There were no differences between the groups in baseline clinical or procedural characteristics. Sixteen patients in the indomethacin group (7.2%) and 11 in the placebo group (4.9%) developed PEP (P = .33). Complications and the severity of PEP were similar between groups. Per a priori protocol guidelines, the study was stopped owing to futility. CONCLUSIONS In a randomized controlled study of consecutive patients undergoing ERCP, rectal indomethacin did not prevent post-ERCP pancreatitis. ClincialTrials.gov no: NCT01774604.
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Affiliation(s)
- John M Levenick
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Section of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania.
| | - Stuart R Gordon
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Linda L Fadden
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - L Campbell Levy
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Matthew J Rockacy
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Sarah M Hyder
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Brian E Lacy
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Steven P Bensen
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Douglas D Parr
- Investigational Pharmacy, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Timothy B Gardner
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
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