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Zeng JQ, Zhang TA, Yang KH, Wang WY, Zhang JY, Hu YB, Xiao J, Gu ZJ, Gong B, Deng ZH. External use of mirabilite to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in children: A multicenter randomized controlled trial. World J Gastrointest Surg 2023; 15:712-722. [PMID: 37206074 PMCID: PMC10190729 DOI: 10.4240/wjgs.v15.i4.712] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/08/2022] [Revised: 12/01/2022] [Accepted: 03/20/2023] [Indexed: 04/22/2023] Open
Abstract
BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Currently, there is no suitable treatment for post-ERCP pancreatitis (PEP) prophylaxis. Few studies have prospectively evaluated interventions to prevent PEP in children.
AIM To assess the efficacy and safety of the external use of mirabilite to prevent PEP in children.
METHODS This multicenter, randomized controlled clinical trial enrolled patients with chronic pancreatitis scheduled for ERCP according to eligibility criteria. Patients were randomly divided into the external use of mirabilite group (external use of mirabilite in a bag on the projected abdominal area within 30 min before ERCP) and blank group. The primary outcome was the incidence of PEP. The secondary outcomes included the severity of PEP, abdominal pain scores, levels of serum inflammatory markers [tumor necrosis factor-alpha (TNF-α) and serum interleukin-10 (IL-10)], and intestinal barrier function markers [diamine oxidase (DAO), D-lactic acid, and endotoxin]. Additionally, the side effects of topical mirabilite were investigated.
RESULTS A total of 234 patients were enrolled, including 117 in the external use of mirabilite group and the other 117 in the blank group. The pre-procedure and procedure-related factors were not significantly different between the two groups. The incidence of PEP in the external use of mirabilite group was significantly lower than that in the blank group (7.7% vs 26.5%, P < 0.001). The severity of PEP decreased in the mirabilite group (P = 0.023). At 24 h after the procedure, the visual analog scale score in the external use of mirabilite group was lower than that in the blank group (P = 0.001). Compared with those in the blank group, the TNF-α expressions were significantly lower and the IL-10 expressions were significantly higher at 24 h after the procedure in the external use of mirabilite group (P = 0.032 and P = 0.011, respectively). There were no significant differences in serum DAO, D-lactic acid, and endotoxin levels before and after ERCP between the two groups. No adverse effects of mirabilite were observed.
CONCLUSION External use of mirabilite reduced the PEP occurrence. It significantly alleviated post-procedural pain and reduced inflammatory response. Our results favor the external use of mirabilite to prevent PEP in children.
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Affiliation(s)
- Jing-Qing Zeng
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Tian-Ao Zhang
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Kai-Hua Yang
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Wen-Yu Wang
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Jia-Yu Zhang
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Ya-Bin Hu
- Department of Clinical Epidemiology and Biostatistics, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Jian Xiao
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Zhi-Jian Gu
- Department of Gastroenterology, Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
| | - Biao Gong
- Department of Gastroenterology, Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
| | - Zhao-Hui Deng
- Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
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Fung BM, Tabibian JH. Biliary endoscopy in the management of primary sclerosing cholangitis and its complications. LIVER RESEARCH (BEIJING, CHINA) 2019; 3:106-117. [PMID: 31341699 PMCID: PMC6656407 DOI: 10.1016/j.livres.2019.03.004] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
Primary sclerosing cholangitis (PSC) is a chronic, idiopathic, cholestatic liver disease characterized by inflammation and fibrosis of the intrahepatic and/or extrahepatic bile ducts. It can affect individuals of all age groups and gender, has no established pharmacotherapy, and is associated with a variety of neoplastic (e.g. cholangiocarcinoma) and non-neoplastic (e.g. dominant strictures) hepatobiliary complications. Given these considerations, endoscopy plays a major role in the care of patients with PSC. In this review, we discuss and provide updates regarding endoscopic considerations in the management of hepatobiliary manifestations and complications of PSC. Where evidence is limited, we suggest pragmatic approaches based on currently available data and expert opinion.
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Affiliation(s)
- Brian M. Fung
- University of California Los Angeles-Olive View Internal Medicine Residency Program, Sylmar, CA, USA
| | - James H. Tabibian
- Division of Gastroenterology, Department of Medicine, Olive View-University of California Los Angeles Medical Center, Sylmar, CA, USA
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Serrano JPR, de Moura DTH, Bernardo WM, Ribeiro IB, Franzini TP, de Moura ETH, Brunaldi VO, Salesse MT, Sakai P, De Moura EGH. Nonsteroidal anti-inflammatory drugs versus placebo for post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and meta-analysis. Endosc Int Open 2019; 7:E477-E486. [PMID: 30957004 PMCID: PMC6445649 DOI: 10.1055/a-0862-0215] [Citation(s) in RCA: 44] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/21/2018] [Accepted: 01/29/2019] [Indexed: 02/08/2023] Open
Abstract
Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for treatment of diseases that affect the biliary tree and pancreatic duct. While the therapeutic success rate of ERCP is high, the procedure can cause complications, such as acute pancreatitis (PEP), bleeding, and perforation. This meta-analysis aimed to assess the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing PEP following (ERCP). Materials and methods We searched databases, such as MEDLINE, Embase, and Cochrane Central Library. Only randomized controlled trials (RCTs) that compared the efficacy of NSAIDs and placebo for the prevention of PEP were included. Outcomes assessed included incidence of PEP, severity of pancreatitis, route of administration, and type of NSAIDs. Results Twenty-one RCTs were considered eligible with a total of 6854 patients analyzed. Overall, 3427 patients used NSAIDs before ERCP and 3427 did not use the drugs (control group). In the end, 250 cases of acute pancreatitis post-ERCP were diagnosed in the NSAIDs group and 407 cases in the placebo group. Risk for PEP was lower in the NSAID group (risk difference (RD): -0.05; 95 % confidence interval (CI): -0.07 to - 0.03; number need to treat (NNT), 20; P < 0.05). Use of NSAIDs effectively prevented mild pancreatitis compared with use of placebo (2.5 % vs. 4.1 %; 95 % CI, -0.05 to - 0.01; NNT, 33; P < 0.05), but the information on moderate and severe PEP could not be completely elucidated. Only rectal administration reduced incidence of PEP (6.8 % vs. 13 %; 95 % CI, -0.10 to - 0.04; NNT, 20; P < 0.05). Furthermore, only diclofenac or indomethacin use was effective in preventing PEP. Conclusions Rectal administration of diclofenac and indomethacin significantly reduced risk of developing mild PEP. Further RCTs are needed to compare efficacy between NSAID administration pathways in prevention of PEP after ERCP.
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Affiliation(s)
- Juan Pablo Román Serrano
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Diogo Turiani Hourneaux de Moura
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Wanderley Marques Bernardo
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Igor Braga Ribeiro
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Tomazo Prince Franzini
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Eduardo Turiani Hourneaux de Moura
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | - Vitor Ottoboni Brunaldi
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
| | | | - Paulo Sakai
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HC/FMUSP, Gastrointestinal Endoscopy Unit, São Paulo, Brazil
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Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc 2018; 88:283-291.e3. [PMID: 29653120 DOI: 10.1016/j.gie.2018.03.029] [Citation(s) in RCA: 65] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2017] [Accepted: 03/30/2018] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. METHODS This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. RESULTS Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23). CONCLUSION The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.).
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Affiliation(s)
- Massimo Conio
- Gastroenterology Department, General Hospital, Sanremo (IM)
| | | | - Angelo Caruso
- Gastroenterology and Digestive Endoscopy Department, Azienda Ospedaliera Universitaria di Modena, Sant'Agostino Estense Hospital, Baggiovara (MO)
| | | | - Todd H Baron
- Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Luca De Luca
- Gastroenterology and Digestive Endoscopy Unit, Ospedali Riuniti Marche Nord, Pesaro
| | - Sergio Signorelli
- Gastroenterology and Gastrointestinal Endoscopy Unit, ASST, Papa Giovanni XXIII, Bergamo, Italy
| | - Mattia Crespi
- Gastroenterology Department, General Hospital, Sanremo (IM)
| | - Mario Marini
- Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy
| | - Paolo Ravelli
- Gastroenterology and Gastrointestinal Endoscopy Unit, ASST, Papa Giovanni XXIII, Bergamo, Italy
| | - Rita Conigliaro
- Gastroenterology and Digestive Endoscopy Department, Azienda Ospedaliera Universitaria di Modena, Sant'Agostino Estense Hospital, Baggiovara (MO)
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Rectal Indomethacin Is Protective against Pancreatitis after Endoscopic Retrograde Cholangiopancreatography: Systematic Review and Meta-Analysis. Gastroenterol Res Pract 2018; 2018:9784841. [PMID: 29861721 PMCID: PMC5971281 DOI: 10.1155/2018/9784841] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2017] [Accepted: 12/25/2017] [Indexed: 12/12/2022] Open
Abstract
Background and Aim Rectal indomethacin was reported to be effective for postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) prophylaxis. However, the preventive effect of indomethacin for average-risk patients remains unclear. Recently, some conflicting evidence was addressed by recent articles. We aimed to determine the protective role of indomethacin in PEP based on the latest available literature. Methods A systematic literature search was conducted using PubMed, Embase, Web of Science, and the Cochrane Library to identify related articles published before October 2016. Studies that evaluated the administration of indomethacin in the prevention of PEP were included in the analysis. We adopted a random-effects model to calculate the overall relative risk (RR) and 95% confidence interval (CI). Results Ten trials from an initial search were finally included in the meta-analysis. The administration of rectal indomethacin significantly reduced the incidence of PEP in consecutive ERCP population (RR, 0.63; 95% CI, 0.50–0.77). There was no significant heterogeneity across included studies (I2 = 14.2%, P = 0.31). Further subgroup analyses also revealed that rectal indomethacin could protect the individuals at high and average risks and reduced severity of PEP. Pre-ERCP administration of indomethacin seemed to be better than the post-ERCP given. There was no evidence of significant publication bias. Conclusions Rectal administration of indomethacin is an effective approach to prevent the incidence of PEP in both high- and average-risk populations undergoing ERCP. However, more high-quality RCTs are needed to further investigate the optimal timing for the administration of indomethacin.
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Hatami B, Kashfi SMH, Abbasinazari M, Nazemalhosseini Mojarad E, Pourhoseingholi MA, Zali MR, Mohammad Alizadeh AH. Epinephrine in the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Preliminary Study. Case Rep Gastroenterol 2018; 12:125-136. [PMID: 29805355 PMCID: PMC5968254 DOI: 10.1159/000479494] [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] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2017] [Accepted: 07/10/2017] [Indexed: 01/01/2023] Open
Abstract
BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) ranges between 15 and 20% among patients at high risk of developing PEP. The efficacy of indomethacin administration in the prevention of PEP is rather debatable. In the present randomized trial study, we evaluated whether or not the combination of indomethacin and epinephrine in comparison to the single administration of indomethacin differs in the pathogenesis and prevention of post-ERCP pancreatitis. PATIENTS AND METHODS One hundred and ninety-two patients were randomized in a double-blinded manner into 3 groups: the epinephrine group (group A), the indomethacin group (group B), and the combined epinephrine and indomethacin group (group C). After the procedure, patients were evaluated for the PEP development. RESULTS During the procedure, 66 patients were randomized to the epinephrine group (group A), 68 cases to the indomethacin group (group B), and 58 individuals to the indomethacin-epinephrine group (group C). The mean age of patients in the epinephrine group was 59.59 ± 15.680 years, in the indomethacin group it was 58.06 ± 17.125 years, and in the combination group it was 59.62 ± 15.369 years. In the present study, we did not observe a significant difference between the 3 groups in sex, age, pre-ERCP amylase, lipase, and patient and procedure risk factors including pancreatic duct (PD) dilation (p = 0.404), PD cannulation (p = 0.329), and difficult cannulation (p = 0.076) among others. PEP developed in 7 of the 192 individuals (3.6%), 6 PEP cases occurred in the indomethacin group and 1 in the epinephrine group (p = 0.016). Univariate analysis of risk factors for PEP in patients with and without pancreatitis revealed no significant difference between the pancreatitis group and the non-pancreatitis group. CONCLUSION In comparison to the administration of indomethacin alone, a single application of epinephrine and the combination of epinephrine and indomethacin seem to be effective in reducing the cases of PEP. A further randomized clinical trial with a larger sample size is required to confirm the efficacy of our medication in the prevention of pancreatitis after ERCP.
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Affiliation(s)
- Behzad Hatami
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Seyed Mohammad Hossein Kashfi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Abbasinazari
- Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Ehsan Nazemalhosseini Mojarad
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Amin Pourhoseingholi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Reza Zali
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Amir Houshang Mohammad Alizadeh
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials 2017; 18:513. [PMID: 29096689 PMCID: PMC5667485 DOI: 10.1186/s13063-017-2250-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2017] [Accepted: 10/10/2017] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis. METHODS/DESIGN The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications. DISCUSSION The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.
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Affiliation(s)
- Yang-Yang Qian
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Hui Chen
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Xin-Ying Tang
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Xi Jiang
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Wei Qian
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Wen-Bin Zou
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Lei Xin
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Bo Li
- Department of Anesthesiology, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Yan-Fen Qi
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
| | - Liang-Hao Hu
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Duo-Wu Zou
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Zhen-Dong Jin
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Dong Wang
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Yi-Qi Du
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Luo-Wei Wang
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Feng Liu
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
| | - Zhao-Shen Li
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
- Shanghai Institute of Pancreatic Diseases, Shanghai, China
- National Clinical Research Center of Digestive Diseases, Shanghai, China
| | - Zhuan Liao
- Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433 China
- Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China
- Shanghai Institute of Pancreatic Diseases, Shanghai, China
- National Clinical Research Center of Digestive Diseases, Shanghai, China
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Aabakken L, Karlsen TH, Albert J, Arvanitakis M, Chazouilleres O, Dumonceau JM, Färkkilä M, Fickert P, Hirschfield GM, Laghi A, Marzioni M, Fernandez M, Pereira SP, Pohl J, Poley JW, Ponsioen CY, Schramm C, Swahn F, Tringali A, Hassan C. Role of endoscopy in primary sclerosing cholangitis: European Society of Gastrointestinal Endoscopy (ESGE) and European Association for the Study of the Liver (EASL) Clinical Guideline. J Hepatol 2017; 66:1265-1281. [PMID: 28427764 DOI: 10.1016/j.jhep.2017.02.013] [Citation(s) in RCA: 66] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2017] [Accepted: 02/14/2017] [Indexed: 02/06/2023]
Abstract
This guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE) and of the European Association for the Study of the Liver (EASL) on the role of endoscopy in primary sclerosing cholangitis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations.
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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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Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol 2017; 17:43. [PMID: 28298192 PMCID: PMC5353805 DOI: 10.1186/s12876-017-0599-4] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2016] [Accepted: 03/08/2017] [Indexed: 12/29/2022] Open
Abstract
Background Acute pancreatitis is a severe complication of endoscopic retrograde cholangiopancreatography (ERCP). Previous meta-analyses have shown that indomethacin effectively prevents this complication; however, the data are limited. We performed a systematic review and meta-analysis to clarify the applications for rectal indomethacin. Methods A systematic search was performed in June 2016. Human prospective, randomized, placebo-controlled trials that compared rectally administered indomethacin with a placebo for the prevention of post-ERCP pancreatitis (PEP) were included. A meta-analysis was performed using a random-effects model to assess the outcomes (PEP) using Review Manager 5.0. Results Seven randomized controlled trials met the inclusion criteria (n = 3013). The overall incidence of PEP was significantly lower after prophylactic administration of rectal indomethacin than after administration of the placebo (RR, 0.58, 95% CI, 0.40–0.83; P = 0.004). A subgroup analysis was performed for rectal indomethacin administration compared to a placebo in high-risk patients (RR, 0.46; 95% CI, 0.32–0.65; P < 0.00001) and average-risk patients (RR, 0.75; 95% CI, 0.46–1.22; P = 0.25) and for administration before ERCP (RR, 0.56; 95% CI, 0.39–0.79; P = 0.001) and after the procedure (RR, 0.61; 95% CI, 0.26–1.44; P = 0.26). Conclusions This meta-analysis indicated that prophylactic rectal indomethacin is not suitable for all patients undergoing ERCP but it is safe and effective to prevent PEP in high-risk patients. In addition, rectal indomethacin administration before ERCP is superior to its administration after ERCP for the prevention of PEP. Electronic supplementary material The online version of this article (doi:10.1186/s12876-017-0599-4) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Jianhua Wan
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China
| | - Yuping Ren
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China
| | - Zhenhua Zhu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China
| | - Liang Xia
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.
| | - Nonghua Lu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China
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Talukdar R. Complications of ERCP. Best Pract Res Clin Gastroenterol 2016; 30:793-805. [PMID: 27931637 DOI: 10.1016/j.bpg.2016.10.007] [Citation(s) in RCA: 69] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2016] [Revised: 10/11/2016] [Accepted: 10/21/2016] [Indexed: 01/31/2023]
Abstract
Even though considered safe, endoscopic retrograde cholangiopancreatography (ERCP) is among the endoscopic procedures associated with the highest rate of complications. Post ERCP pancreatitis (PEP) is the most common complication of ERCP. Several independent risk factors have been associated with PEP. Prophylactic PD stenting has been shown to be highly effective in preventing PEP. More recent studies have suggested that NSAIDs, especially rectal indomethacin, could by itself be effective in preventing PEP. However, head to head RCTs comparing PD stents with NSAIDs would be required to confirm this. Other complications include ERCP induced bleeding, perforation, and cholangitis. Bleeding is related to morphological, procedural, and patient related factors. Early identification and correction of the risk factors are of paramount importance in preventing bleeding. Risk of infection is particularly high during ERCP. It is important to ensure complete drainage of obstructed biliary system in order to reduce the risk of post-ERCP cholangitis.
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Affiliation(s)
- Rupjyoti Talukdar
- Asian Institute of Gastroenterology, 6-3-661 Somajiguda, Hyderabad, 500082, Telangana, India; Asian Healthcare Foundation, 6-3-661 Somajiguda, Hyderabad, 500082, Telangana, India.
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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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