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Ammer‐Herrmenau C, Shumilov E. Pancreatic Exocrine Insufficiency and Adenovirus-Is There a Link? United European Gastroenterol J 2025; 13:184-185. [PMID: 39927739 PMCID: PMC11975602 DOI: 10.1002/ueg2.12771] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2025] [Accepted: 01/23/2025] [Indexed: 02/11/2025] Open
Affiliation(s)
- Christoph Ammer‐Herrmenau
- Department of Gastroenterology, Gastrointestinal Oncology and EndocrinologyUniversity Medical Center GoettingenGottingenGermany
| | - Evgenii Shumilov
- Department of Medicine A for Hematology, Oncology and PneumologyUniversity Hospital MuensterMuensterGermany
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Zemrani B, Krattinger LF, Giuffrida F, Corthésy J, Ran-Ressler RR, Benyacoub J. Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies. Clin Nutr ESPEN 2025; 65:339-347. [PMID: 39681164 DOI: 10.1016/j.clnesp.2024.12.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2024] [Revised: 12/10/2024] [Accepted: 12/12/2024] [Indexed: 12/18/2024]
Abstract
BACKGROUND & AIMS Enteral formulas containing predigested lipids to support the needs of patients with fat maldigestion are currently unavailable. Monoacylglycerol (MAG)-rich oils offer potential benefits for fat absorption without prior digestion, but their safety and tolerability in enteral formulas need evaluation. We assessed the safety and tolerability of a new formula containing predigested lipids in the form of MAG-rich oil. METHODS Two cohorts of healthy volunteers, consisting of 12 adults (aged ≥18 years) followed by 12 adolescents (aged 12-17 years) were recruited. Participants consumed an oral nutritional supplement containing MAG-rich oil as the main lipid source (up to 37 g/day) three times daily for 13 days. Safety, tolerability, gastrointestinal (GI) symptoms, anthropometric, and blood parameters were assessed. RESULTS All 24 participants completed the study without discontinuing the formula with good compliance. Median Visual Analog Scale scores for GI symptoms were low (on average 0.2 out of 10) in both groups, and the Gastrointestinal Symptom Rating Scale scores remained mostly unchanged (1-2 out of 7), indicating no or minimal discomfort. Stool frequency and consistency remained within normal limits throughout the study. Serum triglyceride and cholesterol levels showed no clinically significant changes, and the fatty acid profile and fat-soluble vitamins showed a favorable trend at the end of the study. Adverse events (AEs) were minor, and none were serious. CONCLUSIONS The new formula containing MAG-rich oil was safe and well tolerated in healthy adults and adolescents. This formula could potentially address a gap in the nutritional management of patients with EPI and fat maldigestion. Further studies are required to assess the efficacy of this new formula in the target population. TRIAL REGISTRATION https://clinicaltrials.gov/: NCT05100901 and NCT05923593.
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Affiliation(s)
- Boutaina Zemrani
- Clinical Research and Development, Pediatric Nutrition, Société des Produits Nestlé, Vevey, Switzerland.
| | | | - Francesca Giuffrida
- Nestlé Institute of Food Safety and Analytical Sciences, Société des Produits Nestlé, Lausanne, Switzerland
| | - John Corthésy
- Nestlé Institute of Food Safety and Analytical Sciences, Société des Produits Nestlé, Lausanne, Switzerland
| | - Rinat Rivka Ran-Ressler
- Nutrition, Science & Technology, Nestle Product Technology Center, Nestlé Health Science Bridgewater, New Jersey, USA
| | - Jalil Benyacoub
- Medical Affairs, Pediatric Medical Nutrition, Nestlé Health Science, Switzerland
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Dominguez‐Muñoz JE, Vujasinovic M, de la Iglesia D, Cahen D, Capurso G, Gubergrits N, Hegyi P, Hungin P, Ockenga J, Paiella S, Perkhofer L, Rebours V, Rosendahl J, Salvia R, Scheers I, Szentesi A, Bonovas S, Piovani D, Löhr JM. European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations. United European Gastroenterol J 2025; 13:125-172. [PMID: 39639485 PMCID: PMC11866322 DOI: 10.1002/ueg2.12674] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 08/12/2024] [Indexed: 12/07/2024] Open
Abstract
Pancreatic exocrine insufficiency (PEI) is defined as a reduction in pancreatic exocrine secretion below the level that allows the normal digestion of nutrients. Pancreatic disease and surgery are the main causes of PEI. However, other conditions and upper gastrointestinal surgery can also affect the digestive function of the pancreas. PEI can cause symptoms of nutritional malabsorption and deficiencies, which affect the quality of life and increase morbidity and mortality. These guidelines were developed following the United European Gastroenterology framework for the development of high-quality clinical guidelines. After a systematic literature review, the evidence was evaluated according to the Oxford Center for Evidence-Based Medicine and the Grading of Recommendations Assessment, Development, and Evaluation methodology, as appropriate. Statements and comments were developed by the working groups and voted on using the Delphi method. The diagnosis of PEI should be based on a global assessment of symptoms, nutritional status, and a pancreatic secretion test. Pancreatic enzyme replacement therapy (PERT), together with dietary advice and support, are the cornerstones of PEI therapy. PERT is indicated in patients with PEI that is secondary to pancreatic disease, pancreatic surgery, or other metabolic or gastroenterological conditions. Specific recommendations concerning the management of PEI under various clinical conditions are provided based on evidence and expert opinions. This evidence-based guideline summarizes the prevalence, clinical impact, and general diagnostic and therapeutic approaches for PEI, as well as the specifics of PEI in different clinical conditions. Finally, the unmet needs for future research are discussed.
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Affiliation(s)
- J. Enrique Dominguez‐Muñoz
- Department of Gastroenterology and HepatologyUniversity Hospital of Santiago de CompostelaSantiago de CompostelaSpain
| | - Miroslav Vujasinovic
- Department of MedicineKarolinska Institutet and Department of Upper Abdominal DiseasesKarolinska University HospitalStockholmSweden
| | | | - Djuna Cahen
- Department of Gastroenterology and HepatologyErasmus MC University Medical CenterRotterdamThe Netherlands
| | - Gabriele Capurso
- Department of GastroenterologySan Raffaele University HospitalMilanItaly
| | | | - Peter Hegyi
- Centre for Translational MedicineSemmelweis UniversityBudapestHungary
- Institute for Translational MedicineMedical SchoolUniversity of PécsPécsHungary
- Institute of Pancreatic DiseasesSemmelweis UniversityBudapestHungary
- Translational Pancreatology Research GroupInterdisciplinary Center of Excellence for Research and Development and InnovationUniversity of SzegedSzegedHungary
| | - Pali Hungin
- Faculty of Medical SciencesNewcastle UniversityNewcastle‐upon‐TyneUK
| | - Johann Ockenga
- Department of GastroenterologyEndocrinology and Clinical NutritionKlinikum Bremen MitteBremenGermany
| | - Salvatore Paiella
- Unit of Pancreatic SurgeryUniversity of Verona Hospital TrustVeronaItaly
| | - Lukas Perkhofer
- Department of Internal Medicine ISection of Interdisciplinary PancreatologyUlm University HospitalUlmGermany
| | - Vinciane Rebours
- Department of PancreatologyBeaujon HospitalDMU DigestAP‐HPClichyFrance
| | - Jonas Rosendahl
- Department of Internal Medicine IMartin Luther UniversityHalleGermany
| | - Roberto Salvia
- Unit of Pancreatic SurgeryUniversity of Verona Hospital TrustVeronaItaly
| | - Isabelle Scheers
- Pediatric GastroenterologyHepatology and Nutrition UnitCliniques Universitaires Saint‐LucUniversité Catholique de LouvainBrusselsBelgium
| | - Andrea Szentesi
- Institute for Translational MedicineMedical SchoolUniversity of PécsPécsHungary
| | - Stefanos Bonovas
- Department of Biomedical SciencesHumanitas UniversityMilanItaly
- IRCCS Humanitas Research HospitalMilanItaly
| | - Daniele Piovani
- Department of Biomedical SciencesHumanitas UniversityMilanItaly
- IRCCS Humanitas Research HospitalMilanItaly
| | - J. Matthias Löhr
- Department of Clinical SciencesKarolinska Institutet and Department of Upper Abdominal DiseasesKarolinska University HospitalStockholmSweden
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Lee JM, Lee SH, Choi YH, Han SY, Jo JH, Choe JW, Kim EJ, Jang DK, Jung MK. Association between severity of pancreatic exocrine insufficiency and computed tomography-based morphological severity in patients with chronic pancreatitis. Medicine (Baltimore) 2024; 103:e40737. [PMID: 39612393 PMCID: PMC11608721 DOI: 10.1097/md.0000000000040737] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2023] [Accepted: 11/11/2024] [Indexed: 12/01/2024] Open
Abstract
The association between pancreatic exocrine insufficiency (PEI) and morphologic findings in chronic pancreatitis has not yet been fully studied. Thus, the aim of this study was to investigate the correlation between PEI severity and computed tomography (CT)-based morphological severity in patients with chronic pancreatitis. This nationwide survey included 180 Korean participants with chronic pancreatitis aged 18 years or older between January 2018 and December 2021. PEI severity was measured by the PEI questionnaire (PEI-Q). Morphological severity was measured using a CT-based scoring system, which included pancreatic duct caliber, pancreatic duct stricture or intraductal obstructing calculus, pancreatic atrophy, and pancreatic calcification. In addition, 35 patients who received pancreatic enzyme replacement therapy (PERT) were evaluated by PEI-Q to determine whether PEI improved after PERT. PEI severity was normal (n = 89), mild (n = 69), moderate (n = 14), or severe (n = 8). Severities of pancreatic duct caliber and pancreatic duct stricture or intraductal obstructing calculus had small but significant associations with PEI severity (Cramer V = 0.121 and 0.141, respectively). Severities of pancreatic atrophy and pancreatic calcification were not significantly associated with PEI severity. PEI severity showed a significant improvement after PERT (P < .001). In conclusion, PEI severity had significant associations with CT-based morphological severities, including severities of pancreatic duct caliber and pancreatic duct stricture or intraductal obstructing calculus. In addition, PEI-Q could be a useful indicator for evaluating the therapeutic effect of PERT in clinical practice.
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Affiliation(s)
- Jae Min Lee
- Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University College of Medicine, Changwon, Korea
| | - Sang Hyub Lee
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
| | - Young Hoon Choi
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Sung Yong Han
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Jung Hyun Jo
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Jung Wan Choe
- Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea
| | - Eui Joo Kim
- Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
| | - Dong Kee Jang
- Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea
| | - Min Kyu Jung
- Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea
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Al-Habsi N, Al-Khalili M, Haque SA, Elias M, Olqi NA, Al Uraimi T. Health Benefits of Prebiotics, Probiotics, Synbiotics, and Postbiotics. Nutrients 2024; 16:3955. [PMID: 39599742 PMCID: PMC11597603 DOI: 10.3390/nu16223955] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Revised: 11/13/2024] [Accepted: 11/14/2024] [Indexed: 11/29/2024] Open
Abstract
The trillions of microbes that constitute the human gut microbiome play a crucial role in digestive health, immune response regulation, and psychological wellness. Maintaining gut microbiota is essential as metabolic diseases are associated with it. Functional food ingredients potentially improving gut health include prebiotics, probiotics, synbiotics, and postbiotics (PPSPs). While probiotics are living bacteria that provide health advantages when ingested sufficiently, prebiotics are non-digestible carbohydrates that support good gut bacteria. Synbiotics work together to improve immunity and intestinal health by combining probiotics and prebiotics. Postbiotics have also demonstrated numerous health advantages, such as bioactive molecules created during probiotic fermentation. According to a recent study, PPSPs can regulate the synthesis of metabolites, improve the integrity of the intestinal barrier, and change the gut microbiota composition to control metabolic illnesses. Additionally, the use of fecal microbiota transplantation (FMT) highlights the potential for restoring gut health through microbiota modulation, reinforcing the benefits of PPSPs in enhancing overall well-being. Research has shown that PPSPs provide several health benefits, such as improved immunological function, alleviation of symptoms associated with irritable bowel disease (IBD), decreased severity of allergies, and antibacterial and anti-inflammatory effects. Despite encouraging results, many unanswered questions remain about the scope of PPSPs' health advantages. Extensive research is required to fully realize the potential of these functional food components in enhancing human health and well-being. Effective therapeutic and prophylactic measures require further investigation into the roles of PPSPs, specifically their immune-system-modulating, cholesterol-lowering, antioxidant, and anti-inflammatory characteristics.
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Affiliation(s)
- Nasser Al-Habsi
- Department of Food Science and Nutrition, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman; (M.A.-K.); (M.E.); (N.A.O.); (T.A.U.)
| | - Maha Al-Khalili
- Department of Food Science and Nutrition, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman; (M.A.-K.); (M.E.); (N.A.O.); (T.A.U.)
| | - Syed Ariful Haque
- Department of Marine Science and Fisheries, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman
- Department of Fisheries, Bangamata Sheikh Fojilatunnesa Mujib Science and Technology University, Melandah, Jamalpur 2012, Bangladesh
| | - Moussa Elias
- Department of Food Science and Nutrition, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman; (M.A.-K.); (M.E.); (N.A.O.); (T.A.U.)
| | - Nada Al Olqi
- Department of Food Science and Nutrition, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman; (M.A.-K.); (M.E.); (N.A.O.); (T.A.U.)
| | - Tasnim Al Uraimi
- Department of Food Science and Nutrition, College of Agricultural and Marine Sciences, Sultan Qaboos University, Al-Khodh 123, Muscat P.O. Box 34, Oman; (M.A.-K.); (M.E.); (N.A.O.); (T.A.U.)
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Chu P, Mioc J, O’Donovan P, Henry O. Clinical Efficacy and Safety of Treatments for Exocrine Pancreatic Insufficiency: A Systematic Literature Review. Digestion 2024; 106:45-61. [PMID: 39299226 PMCID: PMC11825132 DOI: 10.1159/000541326] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/08/2023] [Accepted: 08/08/2024] [Indexed: 09/22/2024]
Abstract
INTRODUCTION Exocrine pancreatic insufficiency (EPI) is caused by multiple clinical conditions such as cystic fibrosis and chronic pancreatitis (CP). Standard management of EPI includes pancreatic enzyme replacement therapy (PERT) along with consultation with a dietitian. While PERTs have been on the market for several decades, newer publications on their clinical efficacy and safety raised the need for a comprehensive review of the literature. We aimed to identify the available evidence on the clinical efficacy and safety of treatments for EPI to understand the current treatment landscape and unmet need in patients with EPI. METHODS A systematic literature review (SLR) was conducted in Embase, Medline, and Evidence-Based Medicine databases from 2010 to 2022; conference proceedings from 2020 to 2022 were also searched. Articles were screened independently by two reviewers at abstract and full-text stage against predefined eligibility criteria. RESULTS We identified 26 journal publications and two conference abstracts, reporting on 22 randomized control trials, four observational studies, and two single-arm interventional studies. The most reported treatment was pancrelipase, specifically Creon® (n = 12). Fourteen studies reported coefficient of fat absorption (CFA) results. Across studies, patients experienced a considerable increase in CFA post-initiation of treatment regardless of intervention or timepoint. Mean change in CFA ranged from 7.5% in patients with CP who received placebo to 36% in patients with CP treated with Creon®. Ten studies reported coefficient of nitrogen absorption (CNA). Where reported, pancrelipase (including Creon®) increased CNA levels in EPI patients compared to placebo. Only one study compared PERT brands head-to-head: no significant differences were reported in the CNA-72 h values (Creon® 82.0% [SE: 1.2] vs. Zenpep® 80.9% [SE: 1.2]). Loss of body weight and low body mass index (BMI) are important features of EPI. Overall, treatment with PERT increased BMI and body weight, or limited their decline, with increases ranging from 0.1 to 6.1 kg. Based on the 18 studies that reported safety outcomes, PERT was considered safe and well tolerated. CONCLUSIONS This SLR confirmed that PERT is an effective and tolerable treatment option for patients with EPI. However, nutritional parameters and health-related quality of life data were sparsely reported, and future clinical trials should look to incorporate these data given their importance in clinical practice and patient outcomes. INTRODUCTION Exocrine pancreatic insufficiency (EPI) is caused by multiple clinical conditions such as cystic fibrosis and chronic pancreatitis (CP). Standard management of EPI includes pancreatic enzyme replacement therapy (PERT) along with consultation with a dietitian. While PERTs have been on the market for several decades, newer publications on their clinical efficacy and safety raised the need for a comprehensive review of the literature. We aimed to identify the available evidence on the clinical efficacy and safety of treatments for EPI to understand the current treatment landscape and unmet need in patients with EPI. METHODS A systematic literature review (SLR) was conducted in Embase, Medline, and Evidence-Based Medicine databases from 2010 to 2022; conference proceedings from 2020 to 2022 were also searched. Articles were screened independently by two reviewers at abstract and full-text stage against predefined eligibility criteria. RESULTS We identified 26 journal publications and two conference abstracts, reporting on 22 randomized control trials, four observational studies, and two single-arm interventional studies. The most reported treatment was pancrelipase, specifically Creon® (n = 12). Fourteen studies reported coefficient of fat absorption (CFA) results. Across studies, patients experienced a considerable increase in CFA post-initiation of treatment regardless of intervention or timepoint. Mean change in CFA ranged from 7.5% in patients with CP who received placebo to 36% in patients with CP treated with Creon®. Ten studies reported coefficient of nitrogen absorption (CNA). Where reported, pancrelipase (including Creon®) increased CNA levels in EPI patients compared to placebo. Only one study compared PERT brands head-to-head: no significant differences were reported in the CNA-72 h values (Creon® 82.0% [SE: 1.2] vs. Zenpep® 80.9% [SE: 1.2]). Loss of body weight and low body mass index (BMI) are important features of EPI. Overall, treatment with PERT increased BMI and body weight, or limited their decline, with increases ranging from 0.1 to 6.1 kg. Based on the 18 studies that reported safety outcomes, PERT was considered safe and well tolerated. CONCLUSIONS This SLR confirmed that PERT is an effective and tolerable treatment option for patients with EPI. However, nutritional parameters and health-related quality of life data were sparsely reported, and future clinical trials should look to incorporate these data given their importance in clinical practice and patient outcomes.
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Affiliation(s)
- Paula Chu
- Organon International GmbH, Lucerne, Switzerland
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Chu P, Mioc J, Henry O, O’Donovan P. The clinical, economic, and humanistic burden of treatments for exocrine pancreatic insufficiency and cost-effectiveness of treatments: A systematic literature review. Medicine (Baltimore) 2024; 103:e39224. [PMID: 39151540 PMCID: PMC11332733 DOI: 10.1097/md.0000000000039224] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2024] [Revised: 07/16/2024] [Accepted: 07/17/2024] [Indexed: 08/19/2024] Open
Abstract
BACKGROUND To examine the burden of exocrine pancreatic insufficiency (EPI), specifically the clinical impact of EPI on patients, their quality of life (QoL) and the cost-effectiveness of existing treatments. METHODS A systematic literature review was conducted using key search terms for the clinical, economic, and humanistic burden. Databases were searched from 2010 to 2022, with articles screened independently by 2 reviewers at abstract and full-text stage against pre-defined eligibility criteria. RESULTS Seventy-one publications were identified that reported relevant clinical, humanistic, and economic data. Prevalence and incidence of EPI varied across identified studies; EPI appears to be especially prevalent as a comorbid condition in patients with cystic fibrosis. EPI has a large impact on QoL, with lower QoL scores in patients with EPI compared with those without EPI. The instruments used to assess QoL, however, were inconsistent across studies. Where reported, economic burden studies highlighted that patients with EPI have higher healthcare resource utilization compared with those without, with costs increasing with disease severity. CONCLUSION This systematic literature review highlights that patients with EPI have higher treatment costs and lower QoL scores than patients without EPI. The prevalence of EPI as a comorbid condition is high, particularly in patients with cystic fibrosis.
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Affiliation(s)
- Paula Chu
- Organon International GmbH, Lucerne, Switzerland
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Kawka M, Lucas A, Riad AM, Hawkins D, de Madaria E, West H, Jakaityte I, Lee MJ, Kouli O, Ruanne R, Gujjuri RR, Brown S, Cambridge WA, Pandanaboyana S, Kamarajah SK, McLean KA. Quality of life instruments in acute and chronic pancreatitis: a consensus-based standards for the selection of health measurement instruments (COSMIN) approach. HPB (Oxford) 2024; 26:859-872. [PMID: 38735815 DOI: 10.1016/j.hpb.2024.04.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2023] [Revised: 04/07/2024] [Accepted: 04/18/2024] [Indexed: 05/14/2024]
Abstract
BACKGROUND Pancreatitis is a common surgical emergency, associated with pain and poor quality of life for patients. However, assessment of patient-reported outcome measures in these patients is unclear. This study aimed to identify and evaluate the methodological quality of the health-related quality of life instruments used for patients with acute or chronic pancreatitis. METHODS Prospective studies that evaluated health-related quality of life in acute or chronic pancreatitis were identified from systematic review of MEDLINE, EMBASE, and Web of Science until 28th June 2023 (PROSPERO: CRD42021274743). Instrument characteristics were extracted, and methodological quality assessed using COSMIN (COnsensus-based Standards for the selection of health status Measurement Instruments) guidelines and GRADE approach. Narrative synthesis was conducted, with recommendations for use based on COSMIN criteria, evaluated according to World Health Organisation (WHO) quality of life domains. RESULTS From 3850 records screened, 41 quality of life instruments were identified across 138 studies included. The majority (69.8%, n = 26) were designed to assess general health-related quality of life, whereas the remainder were abdominal-specific (n = 5) or pancreas-specific (n = 10). Only ten instruments (24.3%) demonstrated sufficient content validity, incorporating items in ≥5 WHO quality of life domains. However, only nine instruments (21.9%) incorporated public and patient involvement. Only the Gastrointestinal Quality of Life Index and PAN-PROMISE met the criteria to be recommended for use based on COSMIN methodological assessment. CONCLUSION There is significant heterogeneity in instruments used to assess quality of life after pancreatitis, with almost all instruments considered insufficient. Robust, validated, and relevant instruments are needed to better understand and determine appropriate interventions to improve quality of life for these patients.
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Othman MO, Forsmark C, Yadav D, Singh VK, Lara LF, Park W, Zhang Z, Yu J, Kort JJ. Development of clinical screening tool for exocrine pancreatic insufficiency in patients with definite chronic pancreatitis. Pancreatology 2024; 24:545-552. [PMID: 38693039 DOI: 10.1016/j.pan.2024.04.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/20/2023] [Revised: 04/05/2024] [Accepted: 04/12/2024] [Indexed: 05/03/2024]
Abstract
BACKGROUND/OBJECTIVES No simple, accurate diagnostic tests exist for exocrine pancreatic insufficiency (EPI), and EPI remains underdiagnosed in chronic pancreatitis (CP). We sought to develop a digital screening tool to assist clinicians to predict EPI in patients with definite CP. METHODS This was a retrospective case-control study of patients with definite CP with/without EPI. Overall, 49 candidate predictor variables were utilized to train a Classification and Regression Tree (CART) model to rank all predictors and select a parsimonious set of predictors for EPI status. Five-fold cross-validation was used to assess generalizability, and the full CART model was compared with 4 additional predictive models. EPI misclassification rate (mRate) served as primary endpoint metric. RESULTS 274 patients with definite CP from 6 pancreatitis centers across the United States were included, of which 58 % had EPI based on predetermined criteria. The optimal CART decision tree included 10 variables. The mRate without/with 5-fold cross-validation of the CART was 0.153 (training error) and 0.314 (prediction error), and the area under the receiver operating characteristic curve was 0.889 and 0.682, respectively. Sensitivity and specificity without/with 5-fold cross-validation was 0.888/0.789 and 0.794/0.535, respectively. A trained second CART without pancreas imaging variables (n = 6), yielded 8 variables. Training error/prediction error was 0.190/0.351; sensitivity was 0.869/0.650, and specificity was 0.728/0.649, each without/with 5-fold cross-validation. CONCLUSION We developed two CART models that were integrated into one digital screening tool to assess for EPI in patients with definite CP and with two to six input variables needed for predicting EPI status.
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Affiliation(s)
| | | | | | | | | | | | - Zuoyi Zhang
- AbbVie Inc., Data & Statistical Sciences, North Chicago, IL, USA
| | - Jun Yu
- AbbVie Inc., Data & Statistical Sciences, North Chicago, IL, USA
| | - Jens J Kort
- AbbVie Inc., Medical Affairs, Mettawa, IL, USA
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Boicean A, Ichim C, Todor SB, Anderco P, Popa ML. The Importance of Microbiota and Fecal Microbiota Transplantation in Pancreatic Disorders. Diagnostics (Basel) 2024; 14:861. [PMID: 38732276 PMCID: PMC11082979 DOI: 10.3390/diagnostics14090861] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2024] [Revised: 04/16/2024] [Accepted: 04/18/2024] [Indexed: 05/13/2024] Open
Abstract
The role of the intestinal microbiota in the diagnosis and treatment of pancreatic diseases is increasingly significant. Consequently, fecal microbiota transplantation (FMT) is emerging as a promising therapeutic avenue for various pancreatic disorders, including cancer, pancreatitis, and type 1 diabetes (T1D). This innovative procedure entails transferring gut microbiota from healthy donors to individuals affected by pancreatic ailments with the potential to restore intestinal balance and alleviate associated symptoms. FMT represents a pioneering approach to improve patient outcomes in pancreatic diseases, offering tailored treatments customized to individual microbiomes and specific conditions. Recent research highlights the therapeutic benefits of targeting the gut microbiota for personalized interventions in pancreatic disorders. However, a comprehensive understanding of the intricate interplay between gut microbiota and pancreatic physiology warrants further investigation. The necessity for additional studies and research endeavors remains crucial, especially in elucidating both adult and pediatric cases affected by pathological pancreatic conditions.
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Affiliation(s)
| | - Cristian Ichim
- Faculty of Medicine, Lucian Blaga University of Sibiu, 550169 Sibiu, Romania; (A.B.); (S.B.T.); (P.A.); (M.L.P.)
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11
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Barkin JA, Delk TB, Powell VJ. Symptoms, burden, and unmet needs of patients living with exocrine pancreatic insufficiency: a narrative review of the patient experience. BMC Gastroenterol 2024; 24:101. [PMID: 38481137 PMCID: PMC10938721 DOI: 10.1186/s12876-024-03188-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2023] [Accepted: 02/26/2024] [Indexed: 03/17/2024] Open
Abstract
Exocrine pancreatic insufficiency (EPI) stems from a deficiency of functional pancreatic enzymes with consequent maldigestion and malnutrition. EPI shares clinical symptoms and manifestations with other disorders and is a considerable burden to individuals affected. In this narrative review, we analyzed the literature to identify relevant publications on living with EPI with the scope of individuating evidence gaps, including those related to symptoms, health-related quality of life (HRQoL), emotional functioning, disease burden, presence of comorbidities, and the use of pancreatic enzyme replacement therapy (PERT). Abdominal pain emerged as one of the most prominent symptoms. HRQoL was affected in EPI, but no articles examined emotional functioning. Comorbidities reported involved other pancreatic disorders, diabetes, gastrointestinal disorders, sarcopenia and osteopenia, cardiovascular disorders, bacterial overgrowth, and nutritional deficiencies. PERT was found to be effective in improving EPI symptoms and was well tolerated by most individuals. Our review revealed a dearth of literature evidence on patients' experience with EPI, such as emotional functioning and disease burden. We also revealed that studies on long-term effects of PERT are missing, as are studies that would help advance the understanding of the disease and its progression, risk/mitigating factors, and comorbidities. Future studies should address these identified gaps.
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Affiliation(s)
- Jodie A Barkin
- University of Miami Miller School of Medicine, 1120 NW 14th St., Clinical Research Building, Suite 1188 (D-49), 33136, Miami, FL, USA.
| | - Trudi B Delk
- Aimmune Therapeutics, a Nestlé Health Science Company, Brisbane, CA, USA
| | - Valerie J Powell
- CorEvitas, LLC, part of Thermo Fisher Scientific, Waltham, MA, USA
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12
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Alexandre-Heymann L, Yaker F, Lassen PB, Dubois-Laforgue D, Larger E. Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case-control study. Diabetol Metab Syndr 2024; 16:39. [PMID: 38331895 PMCID: PMC10854028 DOI: 10.1186/s13098-024-01265-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2023] [Accepted: 01/10/2024] [Indexed: 02/10/2024] Open
Abstract
BACKGROUND Exocrine pancreatic insufficiency (EPI) can be associated with all types of diabetes. Pancreatic enzyme replacement therapy (PERT) has short and long-term benefits in subjects with EPI, but its effects on diabetes control are uncertain. We aimed to study the effects of PERT initiation on glycemic control in subjects with diabetes and EPI from any cause. METHODS In this retrospective study, we compared subjects with EPI and diabetes who were prescribed PERT with subjects with diabetes who had a fecal elastase-1 concentration dosage, but did not receive PERT. The primary outcome was the effect of PERT on hypoglycemia frequency and severity. The secondary outcomes were the effects of PERT on gastro-intestinal disorders, HbA1c and body mass index (BMI). RESULTS 48 subjects were included in each group. Overall, PERT did not have any significant effect on hypoglycemia frequency or severity, but hypoglycemia frequency tended to decrease in subjects with chronic pancreatitis. While 19% of subjects experienced mild hyperglycemia after PERT initiation, we did not report any keto-acidosis or any other severe adverse event. Gastro-intestinal disorders improved in 80% of subjects treated with PERT, versus in 20% of control subjects (p = 0.02). Gastro-intestinal disorders improved in 87% of subjects with recommended dosage of PERT, versus in 50% of subjects with underdosage (NS). HbA1c and BMI evolution did not differ between the groups. CONCLUSIONS PERT initiation is safe in subjects with diabetes and EPI. It does not globally decrease hypoglycemia severity of frequency, but is associated with a decrease in gastro-intestinal disorders. Trial registration Retrospectively registered. The database was registered with the Commission Nationale Informatique et Libertés (CNIL), registration number: 2203351v0. The study was approved by the local ethics committee CLEP, registration number: AAA-2023-09047.
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Affiliation(s)
- Laure Alexandre-Heymann
- Service de Diabétologie, AP-HP, Hôpital Cochin, 123 boulevard de Port-Royal, 75014, Paris, France.
- Institut Cochin, INSERM, CNRS, Université Paris Cité, Paris, France.
| | - Fetta Yaker
- Service de Diabétologie, AP-HP, Hôpital Cochin, 123 boulevard de Port-Royal, 75014, Paris, France
| | - Pierre Bel Lassen
- Sorbonne Université, INSERM, Nutrition and Obesities: Systemic approaches (NutriOmics), Paris, France
- Service de Nutrition, AP-HP, Hôpital Pitié-Salpétrière, Paris, France
| | - Danièle Dubois-Laforgue
- Service de Diabétologie, AP-HP, Hôpital Cochin, 123 boulevard de Port-Royal, 75014, Paris, France
- Institut Cochin, INSERM, CNRS, Université Paris Cité, Paris, France
| | - Etienne Larger
- Service de Diabétologie, AP-HP, Hôpital Cochin, 123 boulevard de Port-Royal, 75014, Paris, France
- Institut Cochin, INSERM, CNRS, Université Paris Cité, Paris, France
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13
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Arvanitakis M, Ockenga J, Bezmarevic M, Gianotti L, Krznarić Ž, Lobo DN, Löser C, Madl C, Meier R, Phillips M, Rasmussen HH, Van Hooft JE, Bischoff SC. ESPEN practical guideline on clinical nutrition in acute and chronic pancreatitis. Clin Nutr 2024; 43:395-412. [PMID: 38169174 DOI: 10.1016/j.clnu.2023.12.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2023] [Accepted: 12/23/2023] [Indexed: 01/05/2024]
Abstract
Both acute and chronic pancreatitis are frequent diseases of the pancreas, which, despite being of benign nature, are related to a significant risk of malnutrition and may require nutritional support. Acute necrotizing pancreatitis is encountered in 20 % of patients with acute pancreatitis, is associated with increased morbidity and mortality, and may require artificial nutrition by enteral or parenteral route, as well as additional endoscopic, radiological or surgical interventions. Chronic pancreatitis represents a chronic inflammation of the pancreatic gland with development of fibrosis. Abdominal pain leading to decreased oral intake, as well as exocrine and endocrine failure are frequent complications of the disease. All of the above represent risk factors related to malnutrition. Therefore, patients with chronic pancreatitis should be considered at risk, screened and supplemented accordingly. Moreover, osteoporosis and increased facture risk should be acknowledged in patients with chronic pancreatitis, and preventive measures should be considered.
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Affiliation(s)
- Marianna Arvanitakis
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, HUB Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
| | - Johann Ockenga
- Department of Gastroenterology, Endocrinology and Clinical Nutrition, Klinikum Bremen Mitte, Bremen, Germany
| | - Mihailo Bezmarevic
- Department of Hepatobiliary and Pancreatic Surgery, Clinic for General Surgery, Military Medical Academy, University of Defense, Belgrade, Serbia
| | - Luca Gianotti
- School of Medicine and Surgery, University of Milano-Bicocca and Department of Surgery, San Gerardo Hospital, Monza, Italy
| | - Željko Krznarić
- Department of Gastroenterology, Hepatology and Nutrition, Clinical Hospital Centre & School of Medicine, Zagreb, Croatia
| | - Dileep N Lobo
- Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, School of Medicine, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | | | - Christian Madl
- Division of Gastroenterology and Hepatology, Krankenanstalt Rudolfstiftung, Krankenanstaltenverbund Wien (KAV), Vienna, Austria
| | - Remy Meier
- AMB-Praxis-MagenDarm Basel, Basel, Switzerland
| | - Mary Phillips
- Department of Nutrition and Dietetics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK
| | - Henrik Højgaard Rasmussen
- Centre for Nutrition and Bowel Disease, Department of Gastroenterology, Aalborg University Hospital, Faculty of Health, Aalborg University, Aalborg, Denmark
| | - Jeanin E Van Hooft
- Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, the Netherlands
| | - Stephan C Bischoff
- Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
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14
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Lewis DM, Rieke JG, Almusaylim K, Kanchibhatla A, Blanchette JE, Lewis C. Exocrine Pancreatic Insufficiency Dosing Guidelines for Pancreatic Enzyme Replacement Therapy Vary Widely Across Disease Types. Dig Dis Sci 2024; 69:615-633. [PMID: 38117426 DOI: 10.1007/s10620-023-08184-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2023] [Accepted: 11/06/2023] [Indexed: 12/21/2023]
Abstract
BACKGROUND Pancreatic enzyme replacement therapy (PERT) is the standard treatment for exocrine pancreatic insufficiency (EPI). However, many individuals are inadequately treated, with gaps in clinical dosing, guidelines, and tools to aid individual titration. METHODS A systematic review identified research and guidelines on PERT dosing recommendations across conditions, systematically reviewing and synthesizing total PERT intake, meal/snack guidelines, and changes over time to provide an up-to-date look at the most common doses used in studies and guidelines. RESULTS This review of 257 articles found wide variability in PERT dosing guidelines within and across conditions. Many patients with EPI are underdosed, with guidelines differing globally and by disease type, and clinician prescribing may also play a role. The most common dosing guidelines focus on starting doses at 40,000-50,000 units of lipase/meal with increases of up to two to three times this amount before pursuing additive therapies. Guidelines and studies typically focus only on fat digestion, and comparison by total daily dose shows underdosing is common. Most PERT studies are on safety and efficacy rather than optimal titration. CONCLUSION The current guidelines for PERT in EPI demonstrate substantial variability in dosing recommendations, both within and across disease types. This variation highlights the need for further research to optimize PERT dosing and improve patient outcomes. Healthcare providers should consider individualizing PERT dosing based on nutritional status and response to therapy, ensuring regular follow-up with patients for dose titrations with consideration that most guidelines are framed as initial doses rather than upper limits.
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Affiliation(s)
| | - Jorden G Rieke
- Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, 44106, USA.
| | - Khaleal Almusaylim
- Diabetes and Metabolic Care Center, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA
- School of Medicine, Case Western Reserve University, Cleveland, OH, 44106, USA
| | - Anuhya Kanchibhatla
- Department of Arts and Sciences, Case Western Reserve University, Cleveland, OH, 44106, USA
| | - Julia E Blanchette
- Diabetes and Metabolic Care Center, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA
- School of Medicine, Case Western Reserve University, Cleveland, OH, 44106, USA
| | - Claudia Lewis
- Diabetes and Metabolic Care Center, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA
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15
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Barkin JA, Harb D, Kort J, Barkin JS. Real-World Patient Experience With Pancreatic Enzyme Replacement Therapy in the Treatment of Exocrine Pancreatic Insufficiency. Pancreas 2024; 53:e16-e21. [PMID: 38039440 PMCID: PMC11444357 DOI: 10.1097/mpa.0000000000002273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2022] [Accepted: 09/26/2023] [Indexed: 12/03/2023]
Abstract
OBJECTIVES This study aimed to provide patients insights on the management of exocrine pancreatic insufficiency (EPI) with pancreatic enzyme replacement therapy (PERT). MATERIALS AND METHODS A survey of 75 members of Inspire's Pancreatitis or Pancreatic Cancer Support communities was conducted. Eligibility included having EPI secondary to chronic pancreatitis, pancreatic cancer, pancreatic surgery, or acute pancreatitis, and current/past PERT experience. RESULTS Patients were 73% female, 57% aged 50 to 69 years, and 85% White, with PERT prescribed by a gastroenterologist/pancreatologist for 64%. Only approximately half of respondents agreed that their healthcare provider provided detailed information about EPI (54%) or how PERT works to treat EPI (56%). Most respondents (83%) reported searching for information about EPI, 56% were taking PERT solely before or after eating, 36% reported taking suboptimal PERT doses, and 39% reported no follow-up. In addition, 24% decreased their PERT dosage without consulting their physician, and 21% reported purposely skipping PERT. CONCLUSIONS This study reveals potential barriers to effective treatment of EPI with PERT, including lack of patient education, mainly how and when to take PERT, gaps in appropriate dosing, and lack of patient follow-up. Continued focus on patient and provider education is essential to address these gaps and optimize the treatment of EPI.
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Affiliation(s)
- Jodie A. Barkin
- From the Department of Medicine, Division of Digestive Health and Liver Diseases, University of Miami, Leonard M. Miller School of Medicine, Miami, FL
| | | | | | - Jamie S. Barkin
- From the Department of Medicine, Division of Digestive Health and Liver Diseases, University of Miami, Leonard M. Miller School of Medicine, Miami, FL
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16
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Chen JY, Wang YC, Xi HJ, Tao H, Zhao Q, Yu MT, Xin L, Hu LH, He Q, Zou WB, Peng YQ. Translation and validation of a Chinese version of the pancreatitis quality of life instrument (PANQOLI) in patients with chronic pancreatitis. Qual Life Res 2023; 32:3417-3426. [PMID: 37481482 DOI: 10.1007/s11136-023-03479-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/07/2023] [Indexed: 07/24/2023]
Abstract
PURPOSE Chronic pancreatitis (CP) is a chronic fibroinflammatory pancreatic disease that severely impacts patients' quality of life (QoL). The Pancreatitis Quality of Life Instrument (PANQOLI) is an 18-item measure specifically designed to assess QoL amongst patients with CP. This study aimed to develop a Chinese version of PANQOLI and assess its reliability and validity in the Chinese CP cohort. METHODS Translation was performed according to forward-backwards translation steps and transcultural adaptation. Five hundred Mandarin Chinese-speaking patients with CP were enrolled, 250 for the exploratory factor analysis (EFA) and 250 for the confirmatory factor analysis (CFA). Item analysis, reliability analysis (internal consistency, split-half reliability, test-retest reliability), and validity analysis (content validity, construct validity, and convergent validity) were performed. RESULTS Item analysis of the Chinese version of PANQOLI revealed that the absolute t values of all items were > 3. Reliability analysis showed that Cronbach's α coefficient was 0.868, split-half coefficient was 0.934, and intraclass correlation coefficient was 0.859, demonstrating excellent reliability. For content validity, item level content validity index (I-CVI) ranged from 0.8 to 1.0, and average of I-CVI scores across all items (S-CVI/Ave) was 0.91. In construct validity analysis, EFA produced four dimensions after rotation, and results of CFA showed χ2/df = 2.346, comparative fit index (CFI) = 0.929, Tucker-Lewis index (TLI) = 0.915, and root-mean-square error of approximation (RMSEA) = 0.074. The analysis of convergent validity indicated that the Chinese version of PANQOLI was moderately correlated with the physical (r = 0.436, P < 0.001) and mental component summary (r = 0.518, P < 0.001) of the 36-Item Short Form Health Survey. CONCLUSION The Chinese version of PANQOLI appears to be culturally appropriate, reliable, and valid for assessing the QoL amongst Chinese patients with CP.
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Affiliation(s)
- Jia-Yun Chen
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
- Department of Nursing, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China
| | - Yuan-Chen Wang
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
- Shanghai Institute of Pancreatic Diseases, Shanghai, China
| | - Hui-Jun Xi
- Medical Security Center, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Hong Tao
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
| | - Qi Zhao
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
| | - Meng-Ting Yu
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
| | - Lei Xin
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
| | - Liang-Hao Hu
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China
| | - Qian He
- Department of Military Health Statistics, Naval Medical University, Shanghai, China
| | - Wen-Bin Zou
- Department of Gastroenterology, Digestive Endoscopy Center, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, 168 Changhai Road, Shanghai, 200433, China.
- Shanghai Institute of Pancreatic Diseases, Shanghai, China.
| | - You-Qing Peng
- Department of Nursing, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.
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17
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Zhou Y, Huang RQ, Wu QW, Xu JJ, Yi JH, Chen C, Lu GT, Li ZS, Wang D, Hu LH. Adherence to pancreatic enzyme replacement therapy among patients with chronic pancreatitis in East China: a mixed methods study. Sci Rep 2023; 13:17147. [PMID: 37816878 PMCID: PMC10564898 DOI: 10.1038/s41598-023-44519-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Accepted: 10/09/2023] [Indexed: 10/12/2023] Open
Abstract
Pancreatic enzyme replacement therapy (PERT) has been recommended as the preferred method for pancreatic exocrine insufficiency caused by chronic pancreatitis (CP). However, at present, the patient-related factors for the poor PERT management are not clear, and there are no studies on the adherence to PERT in patients with CP in East China. This was a mixed-method study following the principle of sequential explanatory design and included two parts: a quantitative and qualitative study. A cross-sectional survey of medication adherence (MA) was first carried out, followed by a semi-structured interview to further explore and explain the influencing factors of adherence to PERT. Of the 148 patients included in this study, 48.0% had poor MA and only 12.8% had good MA. Multivariate logistic regression showed that lower levels of education and income were contributing factors for non-adherence to PERT. Semi-structured interviews with 24 patients revealed that the reasons for non-adherence also included lack of knowledge, self-adjustment of PERT, lifetime of medication, side effects of PERT, forgetfulness, financial burdens, and accessibility issues. The adherence to PERT was poor among patients with CP in East China. Healthcare providers should personalize medication strategies to improve patients' MA.
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Affiliation(s)
- You Zhou
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
- School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
- Pancreatic Center, Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Ren-Qian Huang
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Qi-Wei Wu
- Faculty of Nursing, School of Medicine, Zhejiang University, Hangzhou, China
| | - Jin-Jie Xu
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Jin-Hui Yi
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Cui Chen
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Guo-Tao Lu
- Pancreatic Center, Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Zhao-Shen Li
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Dan Wang
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
| | - Liang-Hao Hu
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
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18
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Mathew A, Fernandes D, Andreyev HJN. What is the significance of a faecal elastase-1 level between 200 and 500μg/g? Frontline Gastroenterol 2023; 14:371-376. [PMID: 37581180 PMCID: PMC10423608 DOI: 10.1136/flgastro-2022-102271] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/20/2022] [Accepted: 01/26/2023] [Indexed: 08/16/2023] Open
Abstract
Background Pancreatic exocrine insufficiency is a cause of malabsorption. It is generally diagnosed if faecal elastase-1 (FE-1) levels are below 200 µg/g. Pancreatic function is assumed to be normal when faecal elastase levels are >500 µg/g. The significance of faecal elastase levels above 200 µg/g but less than 500 µg/g is unclear. Methods This retrospective study reports the response to treatment in patients who had an FE-1 level between 200 and 500 µg/g. Results Of these 82 patients, 28 were offered pancreatic enzyme replacement therapy (PERT). A clinical response, defined as an improvement in their initial symptoms after commencing PERT, was seen in 20 patients (71%), 7 with potentially predisposing conditions and 13 with functional diarrhoea. PERT particularly abolished or improved diarrhoea, steatorrhoea and flatulence. Conclusion Clinicians should, therefore, be aware that a trial of PERT given to patients with FE-1 levels between 200 and 500 µg/g may lead to improvement in gastrointestinal symptoms.
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Affiliation(s)
| | - Darren Fernandes
- Department of Gastroenterology, United Lincolnshire Hospitals NHS Trust, Lincoln, UK
- School of Health and Social Care, Community and Health Research Unit, University of Lincoln, Lincoln, UK
| | - H Jervoise N Andreyev
- Department of Gastroenterology, United Lincolnshire Hospitals NHS Trust, Lincoln, UK
- The Biomedical Research Centre, Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK
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19
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Chen M, Dunn TB. Pancreas Transplant for Combined Pancreatic Endocrine and Exocrine Insufficiency. CURRENT TRANSPLANTATION REPORTS 2022. [DOI: 10.1007/s40472-022-00361-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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20
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Perito ER, Pohl JF, Bakker C, Armfield MA, Barth B, Cuneo A, Mascarenhas M, Mehta M, Schwarzenberg SJ. Outpatient Pain Management in Children With Chronic Pancreatitis: A Scoping Systematic Review. Pancreas 2022; 51:135-147. [PMID: 35404888 PMCID: PMC9009154 DOI: 10.1097/mpa.0000000000001973] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
OBJECTIVES Although pain management is central to pediatric chronic pancreatitis (CP) care, no evidence-based guidelines exist. In this scoping systematic review, we sought promising strategies for CP pain treatment in children. METHODS We systematically reviewed literature on pain management in children and adults with CP, and 2 conditions with similar pain courses: juvenile idiopathic arthritis and sickle cell disease. RESULTS Of 8997 studies identified, 287 met inclusion criteria. There are no published studies of analgesic medications, antioxidants, dietary modification, integrative medicine, or regional nerve blocks in children with CP. In adults with CP, studies of nonopioid analgesics, pancreatic enzymes, and dietary interventions have mixed results. Retrospective studies suggest that endoscopic retrograde cholangiopancreatography and surgical procedures, most durably total pancreatectomy with islet autotransplant, improve pain for children with CP. Follow-up was short relative to a child's life. Large studies in adults also suggest benefit from endoscopic therapy and surgery, but lack conclusive evidence about optimal procedure or timing. Studies on other painful pediatric chronic illnesses revealed little generalizable to children with CP. CONCLUSIONS No therapy had sufficient high-quality studies to warrant untempered, evidence-based support for use in children with CP. Multicenter studies are needed to identify pain management "best practices."
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Affiliation(s)
- Emily R. Perito
- Department of Pediatrics, University of California San Francisco, San Francisco, CA
| | - John F. Pohl
- Department of Pediatrics, University of Utah, Salt Lake City, UT
| | | | - Matthew A. Armfield
- Department of Pediatrics, University of Minnesota Masonic Children’s Hospital, Minneapolis, MN
| | - Bradley Barth
- Department of Pediatrics, University of Texas Southwestern and Children’s Medical Center Dallas, Dallas, TX
| | - Addison Cuneo
- Department of Pediatrics, University of California San Francisco, San Francisco, CA
| | - Maria Mascarenhas
- Department of Pediatrics, Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, PA
| | - Megha Mehta
- Department of Pediatrics, University of Texas Southwestern and Children’s Medical Center Dallas, Dallas, TX
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21
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Asare E, Yang Z, Yang H, Wang Z. Evaluation of dietary Pancreatin as an exogenous enzyme on growth performance, gene expression, immunological responses, serum immunoglobins, and intestinal morphology in cockerels. JOURNAL OF APPLIED ANIMAL RESEARCH 2022. [DOI: 10.1080/09712119.2021.2019044] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Affiliation(s)
- Emmanuel Asare
- Department of Animal Nutrition and Feed Science, College of Animal Science and Technology, Yangzhou University, Yangzhou, P.R. China
| | - Zhi Yang
- Joint International Research Laboratory of Agriculture and Agric-Product Safety of Ministry of Education of China, Yangzhou University, Yangzhou, P.R. China
| | - Haiming Yang
- Department of Animal Nutrition and Feed Science, College of Animal Science and Technology, Yangzhou University, Yangzhou, P.R. China
| | - Zhiyue Wang
- Department of Animal Nutrition and Feed Science, College of Animal Science and Technology, Yangzhou University, Yangzhou, P.R. China
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22
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Kucheryavyy YA, Bordin DS. A brief review of clinical guidelines for the diagnosis and treatment of exocrine pancreatic insufficiency. EXPERIMENTAL AND CLINICAL GASTROENTEROLOGY 2022:5-14. [DOI: 10.31146/1682-8658-ecg-195-11-5-14] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/20/2023]
Abstract
In recent years, several consensus and guidelines for the diagnosis and treatment of chronic pancreatitis have been published. In 2017, the Russian and Pan-European (HaPanEU) consensus was published, in 2018 — the international consensus on minimal change pancreatitis, in 2020 — the clinical guidelines of the American College of Gastroenterology, in 2021 — the British clinical guidelines. Many of their provisions overlap. This review article analyzed the main provisions of the latest recommendations, taking into account the possibility of their adaptation to Russian clinical practice.
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Affiliation(s)
| | - D. S. Bordin
- A.S. Loginov Moscow clinical scientific center; A.I. Yevdokimov Moscow State University of Medicine and Dentistry; Tver State Medical University
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Abstract
Chronic pancreatitis is a clinical entity that results from the progressive inflammation and irreversible fibrosis of the pancreas resulting from the cumulative injury sustained by the pancreas over time. It is an illness with variable presentations that can severely impact quality of life, while its long-term complications such as exocrine pancreatic insufficiency (EPI), diabetes mellitus, and risk of pancreatic cancer can become life threatening. The diagnosis of chronic pancreatitis can be challenging as despite the recent advancements in imaging technology, the radiographic findings do not become prominent until late stages of disease. Thus, the physicians' clinical acumen in obtaining thorough history taking focusing on risk factors, clinical symptoms, in addition to high-quality imaging, often guide to the accurate diagnosis of chronic pancreatitis. Endoscopy also plays a pivotal role in the diagnosis and management of chronic pancreatitis. Endoscopic ultrasound (EUS) is believed to be the most sensitive modality for diagnosing chronic pancreatitis. Despite efforts, however, natural history studies have demonstrated that 61% of individuals with chronic pancreatitis will require at least one endoscopic intervention, while 31% will require a surgical procedure as part of their management strategy. Recent advancements in genomic studies have furthered our understanding of the genetic polymorphisms that are associated with the pathogenesis of chronic pancreatitis. Genetic testing offers the potential to reveal treatable pancreatitis-related disorders, and can inform decision making with regard to radical therapies for persistent or severe disease such as total pancreatectomy with islet autotransplantation (TPIAT). The management of patients suffering from chronic pancreatitis often requires a multi-disciplinary approach, addressing pertinent symptoms as well as the sequelae of chronic inflammation and fibrosis. Abdominal pain is the prevailing symptom and most common complication of chronic pancreatitis, and impairs quality of life. Although heavily dependent on a wide range of analgesia, endoscopic treatment such as endoscopic retrograde cholangiopancreatography (ERCP) and surgical intervention can offer long-lasting relief of symptoms. For EPI, treatment with pancreatic enzyme supplements offers marginal-to-moderate relief. The most feared complication of chronic pancreatitis-the development of pancreatic cancer-has no known prevention measure to date.
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Khan M, Rutkowski W, Vujasinovic M, Löhr JM. Adherence to European Guidelines for Treatment and Management of Pancreatic Exocrine Insufficiency in Chronic Pancreatitis Patients. J Clin Med 2021; 10:2737. [PMID: 34205772 PMCID: PMC8233716 DOI: 10.3390/jcm10122737] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/03/2021] [Revised: 06/08/2021] [Accepted: 06/14/2021] [Indexed: 12/16/2022] Open
Abstract
European evidence-based guidelines for the treatment and management of chronic pancreatitis (CP) have been made available following the harmonizing diagnosis and treatment of CP across Europe (HaPanEU) initiative by the United European Gastroenterology (UEG). The aim of this study was to evaluate adherence to the guideline recommendations in the management of patients with pancreatic exocrine insufficiency (PEI) at Karolinska University Hospital in Stockholm. UEG guideline recommendations were evaluated and categorized into 55 different quality indicators (QIs). Data from a retrospective cohort of CP patients being treated at Karolinska University Hospital were evaluated with regard to overall adherence as well as adherence to specific QIs. A total number of 118 patients out of 956 patients diagnosed with CP were eligible for inclusion with mean overall adherence of 61.9% to the defined QIs. A significant difference in mean overall adherence was shown between patients diagnosed with CP prior to 1 January 2016 and following 1 January 2016 (59.3% and 67.7% respectively, p = 0.004), with linear regression analysis also demonstrating improvement correlating to date of diagnosis (p = 0.002). In conclusion, diagnosis and treatment of PEI improved after the HaPanEU guidelines became available and is continuously improving; however, there is room for further improvement.
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Affiliation(s)
- Mashroor Khan
- Department of Medicine Huddinge, Karolinska Institutet, Huddinge, SE-141 86 Stockholm, Sweden; (M.K.); (M.V.)
| | - Wiktor Rutkowski
- Department of Upper Abdominal Diseases, Karolinska University Hospital, Huddinge, SE-141 86 Stockholm, Sweden;
- Department of Clinical Science, Innovation and Technology, Karolinska Institutet, Huddinge, SE-141 86 Stockholm, Sweden
| | - Miroslav Vujasinovic
- Department of Medicine Huddinge, Karolinska Institutet, Huddinge, SE-141 86 Stockholm, Sweden; (M.K.); (M.V.)
- Department of Clinical Science, Innovation and Technology, Karolinska Institutet, Huddinge, SE-141 86 Stockholm, Sweden
| | - Johannes Matthias Löhr
- Department of Upper Abdominal Diseases, Karolinska University Hospital, Huddinge, SE-141 86 Stockholm, Sweden;
- Department of Clinical Science, Innovation and Technology, Karolinska Institutet, Huddinge, SE-141 86 Stockholm, Sweden
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Phillips ME, Hopper AD, Leeds JS, Roberts KJ, McGeeney L, Duggan SN, Kumar R. Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines. BMJ Open Gastroenterol 2021; 8:bmjgast-2021-000643. [PMID: 34140324 PMCID: PMC8212181 DOI: 10.1136/bmjgast-2021-000643] [Citation(s) in RCA: 75] [Impact Index Per Article: 18.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Accepted: 05/08/2021] [Indexed: 12/12/2022] Open
Abstract
INTRODUCTION Pancreatic exocrine insufficiency is a finding in many conditions, predominantly affecting those with chronic pancreatitis, pancreatic cancer and acute necrotising pancreatitis. Patients with pancreatic exocrine insufficiency can experience gastrointestinal symptoms, maldigestion, malnutrition and adverse effects on quality of life and even survival.There is a need for readily accessible, pragmatic advice for healthcare professionals on the management of pancreatic exocrine insufficiency. METHODS AND ANALYSIS A review of the literature was conducted by a multidisciplinary panel of experts in pancreatology, and recommendations for clinical practice were produced and the strength of the evidence graded. Consensus voting by 48 pancreatic specialists from across the UK took place at the 2019 Annual Meeting of the Pancreatic Society of Great Britain and Ireland annual scientific meeting. RESULTS Recommendations for clinical practice in the diagnosis, initial management, patient education and long term follow up were developed. All recommendations achieved over 85% consensus and are included within these comprehensive guidelines.
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Affiliation(s)
- Mary E Phillips
- Nutrition and Dietetics, Royal Surrey Hospital NHS Foundation Trust, Guildford, UK
| | - Andrew D Hopper
- Department of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | - John S Leeds
- HPB Unit, Freeman Hospital, Newcastle Upon Tyne, Tyne and Wear, UK
| | - Keith J Roberts
- HPB Surgery, Queen Elizabeth Hospital Birmingham, Birmingham, UK
| | - Laura McGeeney
- Nutrition and Dietetics, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Sinead N Duggan
- Department of Surgery, Trinity College Dublin, Dublin, Ireland
| | - Rajesh Kumar
- HPB Surgery, Royal Surrey Hospital NHS Foundation Trust, Guildford, UK
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Barkin JA, Barkin JS. Effect of Pancrelipase Therapy on Exocrine Pancreatic Insufficiency Symptoms and Coefficient of Fat Absorption Associated With Chronic Pancreatitis. Pancreas 2021; 50:176-182. [PMID: 33560089 DOI: 10.1097/mpa.0000000000001733] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
OBJECTIVE The aim of this study was to evaluate whether improvement in coefficient of fat absorption (CFA) with pancreatic enzyme replacement therapy correlates with clinical symptoms in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency. METHODS Data were pooled from 2 randomized double-blind trials of the effects of 1 week of pancrelipase (n = 59) versus placebo (n = 57) on CFA and stool frequency, stool consistency, abdominal pain, and flatulence; 1 trial included a 51-week open-label pancrelipase treatment period (n = 34). RESULTS Compared with placebo, significantly more patients receiving pancrelipase reported decreased stool frequency at week 1 (72% vs 38%; P < 0.001). Although 30% of patients receiving pancrelipase and 20% receiving placebo reported improved stool consistency, changes in stool consistency, abdominal pain, and flatulence were not different between groups. Mean CFA absolute change from baseline was significantly greater with pancrelipase versus placebo (24.7% vs 6.4%; P < 0.001). Improvements in stool consistency and frequency correlated with CFA improvement. Symptom improvements persisted or further improved through 52 weeks of treatment. CONCLUSIONS Pancrelipase significantly improved exocrine pancreatic insufficiency maldigestive symptoms. Improvements in objective stool symptoms with pancreatic enzyme replacement therapy correlated with CFA improvement at 1 week.
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Affiliation(s)
- Jodie A Barkin
- From the Division of Gastroenterology, Department of Medicine, University of Miami, Leonard M. Miller School of Medicine, Miami, FL
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Assessment of Weight Loss and Gastrointestinal Symptoms Suggestive of Exocrine Pancreatic Dysfunction After Acute Pancreatitis. Clin Transl Gastroenterol 2020; 11:e00283. [PMID: 33464001 PMCID: PMC7743841 DOI: 10.14309/ctg.0000000000000283] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2020] [Accepted: 11/02/2020] [Indexed: 02/07/2023] Open
Abstract
INTRODUCTION Studies evaluating the natural history of exocrine pancreatic dysfunction (EPD) after acute pancreatitis (AP) are sparse. This study aims to assess incidence and predictors of weight loss and gastrointestinal (GI) symptoms suggestive of EPD 12 months after an AP episode. METHODS Patients enrolled in the Pancreatitis-associated Risk of Organ Failure Study at the time of an AP episode were included. Weight and GI symptom data were prospectively collected by self-report at enrollment and at 3- and 12-month (windows 2-7 and 8-20) telephone follow-ups. Multivariable logistic regression was used to assess factors associated with ≥10% total body weight loss (EPD surrogate) at 12 months. A generalized estimating equation was used to measure each factor's population effect (in pounds) over 12 months after AP. RESULTS Follow-up at 12 months in 186 patients (median age = 54 years, 46% men, 45% biliary, 65% first AP attack) revealed weight loss ≥10% from baseline, occurring in 44 patients (24%). Risk of weight loss increased with higher baseline body mass index, previous diagnosis of diabetes mellitus, and worsening AP severity (all P < 0.010). GI symptoms were reported in 13/31 (42%) patients at 12 months. AP severity was independently associated with ≥10% weight loss at 12 months. Over 12 months, men lost more weight than women (average 9.5 lbs); patients with severe AP lost, on average, 14 lbs. DISCUSSION Weight loss after AP occurs in one-quarter of patients and is associated with AP severity. EPD incidence after AP is likely underappreciated. Further work is needed to assess EPD and potential for pancreatic enzyme supplementation.
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Pancreatic Diseases and Microbiota: A Literature Review and Future Perspectives. J Clin Med 2020; 9:jcm9113535. [PMID: 33139601 PMCID: PMC7692447 DOI: 10.3390/jcm9113535] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2020] [Revised: 10/28/2020] [Accepted: 10/30/2020] [Indexed: 12/12/2022] Open
Abstract
Gut microbiota represent an interesting worldwide research area. Several studies confirm that microbiota has a key role in human diseases, both intestinal (such as inflammatory bowel disease, celiac disease, intestinal infectious diseases, irritable bowel syndrome) and extra intestinal disorders (such as autism, multiple sclerosis, rheumatologic diseases). Nowadays, it is possible to manipulate microbiota by administering prebiotics, probiotics or synbiotics, through fecal microbiota transplantation in selected cases. In this scenario, pancreatic disorders might be influenced by gut microbiota and this relationship could be an innovative and inspiring field of research. However, data are still scarce and controversial. Microbiota manipulation could represent an important therapeutic strategy in the pancreatic diseases, in addition to standard therapies. In this review, we analyze current knowledge about correlation between gut microbiota and pancreatic diseases, by discussing on the one hand existing data and on the other hand future possible perspectives.
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Abstract
Chronic pancreatitis is a complex and irreversible disease of the pancreas and is associated with significant morbidity and mortality. Nutrition deficiencies in chronic pancreatitis are common and can be atypical in nature. As such, the management of these deficiencies can be individualized for patients. The aim of this review is to discuss the components of nutrition deficiencies in chronic pancreatitis, their management, and the current areas of research that are being explored. The clinical guidelines of major national and international societies were analyzed for recommendations on the nutrition management of chronic pancreatitis. The etiology of nutrition deficiencies in chronic pancreatitis is multifactorial and includes aspects of exocrine and/or endocrine dysfunction, significant abdominal pain, often persistent alcohol consumption, and increased metabolic activity. A large number of patients with nutrition deficiencies are underrecognized and undertreated. Although the majority of these patients can be managed by oral and pancreatic enzyme supplementation, some patients may require enteral tube feeding and, in rare cases, parenteral feeding. Current areas of research include the accurate identification of patients at risk for nutrition deficiencies, optimization of feeding regimens, and research into islet cell autotransplantation.
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Affiliation(s)
- Stephen J O'Brien
- Price Institute of Surgical Research, The Hiram C. Polk Jr., MD Department of Surgery, University of Louisville, Louisville, Kentucky, USA
| | - Endashaw Omer
- Division of Gastroenterology, Hepatology, and Nutrition, University of Louisville, Louisville, Kentucky, USA
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Miksch RC, D'Haese JG, Werner J. Surgical Therapy of Chronic Alcoholic Pancreatitis: A Literature Review of Current Options. Visc Med 2020; 36:191-197. [PMID: 32775349 PMCID: PMC7383250 DOI: 10.1159/000508174] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/06/2020] [Accepted: 04/22/2020] [Indexed: 11/19/2022] Open
Abstract
Chronic pancreatitis (CP) is associated with alcohol abuse in 80% of cases. The primary treatment goals in CP are pain reduction and avoidance of pancreatitis-associated complications. CP should be treated in an interdisciplinary approach. A recent randomized clinical trial showed that early surgery compared with an endoscopy-first approach resulted in reduced pain levels. Surgical resections are, therefore, the most efficient treatment of pancreatitis-associated pain as well as other complications and should be performed early in the course of the disease. Since most of the patients pre-sent with chronic inflammation of the pancreatic head, pancreatic head resection is the most common treatment option. Duodenum-preserving pancreatic head resections are the surgical procedure of choice, but pancreaticoduodenectomies (Kausch-Whipple procedures) demonstrate similar outcome with regard to pain control, quality of life, and metabolic parameters. Other surgical procedures, including drainage procedures, pancreatic segmental resections, or left resections, are rarely indicated.
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Affiliation(s)
| | | | - Jens Werner
- Department of General, Visceral, and Transplantation Surgery, Ludwig Maximilian University Munich, Munich, Germany
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31
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Arvanitakis M, Ockenga J, Bezmarevic M, Gianotti L, Krznarić Ž, Lobo DN, Löser C, Madl C, Meier R, Phillips M, Rasmussen HH, Van Hooft JE, Bischoff SC. ESPEN guideline on clinical nutrition in acute and chronic pancreatitis. Clin Nutr 2020; 39:612-631. [PMID: 32008871 DOI: 10.1016/j.clnu.2020.01.004] [Citation(s) in RCA: 132] [Impact Index Per Article: 26.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2019] [Accepted: 01/08/2020] [Indexed: 12/15/2022]
Abstract
Both acute and chronic pancreatitis are frequent diseases of the pancreas, which, despite being of benign nature, are related to a significant risk of malnutrition and may require nutritional support. Acute necrotizing pancreatitis is encountered in 20% of patients with acute pancreatitis, is associated with increased morbidity and mortality, and may require artificial nutrition by enteral or parenteral route, as well as additional endoscopic, radiological or surgical interventions. Chronic pancreatitis represents a chronic inflammation of the pancreatic gland with development of fibrosis. Abdominal pain leading to decreased oral intake, as well as exocrine and endocrine failure are frequent complications of the disease. All of the above represent risk factors related to malnutrition. Therefore, patients with chronic pancreatitis should be considered at risk, screened and supplemented accordingly. Moreover, osteoporosis and increased facture risk should be acknowledged in patients with chronic pancreatitis, and preventive measures should be considered.
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Affiliation(s)
- Marianna Arvanitakis
- Department of Gastroenterology, Erasme University Hospital ULB, Brussels, Belgium.
| | - Johann Ockenga
- Department of Gastroenterology, Endocrinology and Clinical Nutrition, Klinikum Bremen Mitte, Bremen, Germany
| | - Mihailo Bezmarevic
- Department of Hepatobiliary and Pancreatic Surgery, Clinic for General Surgery, Military Medical Academy, University of Defense, Belgrade, Serbia
| | - Luca Gianotti
- School of Medicine and Surgery, University of Milano-Bicocca and Department of Surgery, San Gerardo Hospital, Monza, Italy
| | - Željko Krznarić
- Department of Gastroenterology, Hepatology and Nutrition, Clinical Hospital Centre & School of Medicine, Zagreb, Croatia
| | - Dileep N Lobo
- Gastrointestinal Surgery, Nottingham Digestive Diseases Centre, National Institute for Health Research. (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, UK
| | | | - Christian Madl
- Division of Gastroenterology and Hepatology, Krankenanstalt Rudolfstiftung, Krankenanstaltenverbund Wien (KAV), Vienna, Austria
| | - Remy Meier
- AMB-Praxis-MagenDarm Basel, Basel, Switzerland
| | - Mary Phillips
- Department of Nutrition and Dietetics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK
| | - Henrik Højgaard Rasmussen
- Centre for Nutrition and Bowel Disease, Department of Gastroenterology, Aalborg University Hospital, Faculty of Health, Aalborg University, Aalborg, Denmark
| | - Jeanin E Van Hooft
- Department of Gastroenterology & Hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
| | - Stephan C Bischoff
- Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
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Abstract
Chronic pancreatitis (CP) is historically defined as an irreversible inflammatory condition of the pancreas leading to varying degrees of exocrine and endocrine dysfunction. Recently however, the paradigm for the diagnosis has changed in that it breaks with the traditional clinicopathologic-based definition of disease, focusing instead on diagnosing the underlying pathologic process early in the disease course and managing the syndrome more holistically to change the natural course of disease and minimize adverse disease effects. Currently, the most accepted mechanistically derived definition of CP is a pathologic fibroinflammatory syndrome of the pancreas in individuals with genetic, environmental, and/or other risk factors who develop persistent pathologic responses to parenchymal injury or stress. The most common symptom of CP is abdominal pain, with other symptoms such as exocrine pancreatic insufficiency and diabetes developing at highly variable rates. CP is most commonly caused by toxins such as alcohol or tobacco use, genetic polymorphisms, and recurrent attacks of acute pancreatitis, although no history of acute pancreatitis is seen in many patients. Diagnosis is made usually on cross-sectional imaging, with modalities such as endoscopic ultrasonography and pancreatic function tests playing a secondary role. Total pancreatectomy represents the only known cure for CP, although difficulty in patient selection and the complications inherent to this intervention make it usually an unattractive option. This guideline will provide an evidence-based practical approach to the diagnosis and management of CP for the general gastroenterologist.
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Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology 2020; 158:506-514.e2. [PMID: 31647902 DOI: 10.1053/j.gastro.2019.10.018] [Citation(s) in RCA: 90] [Impact Index Per Article: 18.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2018] [Revised: 09/10/2019] [Accepted: 10/01/2019] [Indexed: 12/17/2022]
Abstract
BACKGROUND & AIMS There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.
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Affiliation(s)
- Philippe Ducrotte
- Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France
| | | | - Bruno Bonaz
- Grenoble University Hospital, Grenoble, France
| | | | | | - Frank Zerbib
- Department of Gastroenterology, Hepatology, and Digestive Oncology, Bordeaux University Hospital, Bordeaux, France
| | | | | | | | | | | | | | | | | | - Romain Altwegg
- Montpellier University Hospital-Lapeyronie, Montpellier, France
| | | | | | - Michel Dapoigny
- Clermont-Ferrand University Hospital, Clermont Ferrand, France
| | - Henri Duboc
- Paris-HP Louis Mourier Hospital, Colombes, France
| | | | | | - Nathalie Donnadieu
- Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France
| | - Guillaume Gourcerol
- Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France.
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Natural Course and Treatment of Pancreatic Exocrine Insufficiency in a Nationwide Cohort of Chronic Pancreatitis. Pancreas 2020; 49:242-248. [PMID: 32011528 DOI: 10.1097/mpa.0000000000001473] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
OBJECTIVES Pancreatic exocrine insufficiency (PEI) is a common complication of chronic pancreatitis. However, little is known about the natural course of PEI and the effect of pancreatic enzyme replacement therapy on symptoms. The aim of this study was to evaluate the natural course and treatment of PEI in a nationwide cohort of patients with chronic pancreatitis. METHODS Patients with chronic pancreatitis were selected from the multicenter Dutch Chronic Pancreatitis Registry. Patients were classified in 3 groups: definite PEI, potential PEI, and no PEI. Definite PEI and no PEI were compared regarding the course of disease, symptoms, treatment, and quality of life. RESULTS Nine hundred eighty-seven patients were included from 29 centers, of which 304 patients (31%) had definite PEI; 451 (46%), potentially PEI; and 232 (24%), no PEI. Patients with definite PEI had significantly more malabsorption symptoms, a lower body mass index, and aberrant defecation. Lowered quality of life was not independently associated with PEI. Of the PEI patients using pancreatic enzyme replacement therapy, 47% still reported steatorrhea. CONCLUSIONS Pancreatic exocrine insufficiency is associated with malabsorption symptoms and a lower body mass index. Some form of pancreatic enzyme replacement therapy is reasonably effective in alleviating malabsorption symptoms, but improvement of treatment is needed.
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Lam KW, Leeds J. How to manage: patient with a low faecal elastase. Frontline Gastroenterol 2019; 12:67-73. [PMID: 33489070 PMCID: PMC7802491 DOI: 10.1136/flgastro-2018-101171] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2019] [Revised: 10/31/2019] [Accepted: 11/04/2019] [Indexed: 02/06/2023] Open
Affiliation(s)
- Kwan Wai Lam
- Pancreaticobiliary Medicine, Freeman Hospital, Newcastle upon Tyne, Newcastle upon Tyne, UK
| | - John Leeds
- Pancreaticobiliary Medicine, Freeman Hospital, Newcastle upon Tyne, Newcastle upon Tyne, UK
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36
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Ru N, Zou WB, Wu H, Hu LH, Li XB, Liu GF, Li ZS, Liao Z. Chinese guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency (2018 edition). J Dig Dis 2019; 20:567-571. [PMID: 31006979 DOI: 10.1111/1751-2980.12753] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2019] [Revised: 04/16/2019] [Accepted: 04/16/2019] [Indexed: 12/11/2022]
Affiliation(s)
- Nan Ru
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China
| | - Wen Bin Zou
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.,Department of Gastroenterology, Shanghai Institute of Pancreatic Diseases, Shanghai, China
| | - Hao Wu
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China
| | - Liang Hao Hu
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China
| | - Xiao Bin Li
- Department of General Surgery, Peking Union Medical College Hospital, Beijing, China
| | - Gai Fang Liu
- Department of Gastroenterology, Hebei People's Hospital, Shijiazhuang, China
| | - Zhao Shen Li
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.,Department of Gastroenterology, Shanghai Institute of Pancreatic Diseases, Shanghai, China
| | - Zhuan Liao
- Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.,Department of Gastroenterology, Shanghai Institute of Pancreatic Diseases, Shanghai, China
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Pancreatic Function in Chronic Pancreatitis: A Cohort Study Comparing 3 Methods of Detecting Fat Malabsorption and the Impact of Short-term Pancreatic Enzyme Replacement Therapy. Pancreas 2019; 48:1068-1078. [PMID: 31404029 PMCID: PMC7243202 DOI: 10.1097/mpa.0000000000001381] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Reliable pancreatic function tests in patients with chronic pancreatitis (CP) are needed. This cohort study identified malabsorption in people with CP compared with healthy people and then investigated short-term pancreatic enzyme replacement therapy (PERT) and fat malabsorption, nutritional status, and quality of life (QOL). METHODS Subjects with CP were evaluated before and after PERT and compared with the healthy cohort using coefficient of fat absorption (CFA), stool bomb calorimetry, and the malabsorption blood test (MBT). Anthropometrics, micronutrients, and QOL data were collected. Group means at baseline and after PERT were analyzed. RESULTS The 24 subjects with CP had greater stool energy loss (5668 cal/g [standard deviation {SD}, 753] vs 5152 cal/g [SD, 418], P < 0.01), reduced triglyceride absorption (MBT, 8.3 mg·h/dL [SD, 4.3] vs 17.7 mg·h/dL [SD, 10.3], P < 0.001), lower fat intake, and poorer QOL. Differences in CFA were not significant (90.9% [SD, 12.8] vs 95.4% [SD, 9.3]). After PERT, triglyceride absorption (Δ = 1.7 [SD, 3], P < 0.05) and QOL increased. CONCLUSIONS The MBT detected changes in triglyceride absorption in the absence of CFA changes. The MBT may be helpful in guiding PERT initiation in patients with CP before significant morbidity.
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Saito T, Nakai Y, Mizuno S, Isayama H, Sasahira N, Watanabe T, Matsubara S, Arizumi T, Togawa O, Hirano K, Tsujino T, Ishigaki K, Hakuta R, Saito K, Takahara N, Hamada T, Kogure H, Tada M, Koike K. A randomized-controlled trial of early endotherapy versus wait-and-see policy for mild symptomatic pancreatic stones in chronic pancreatitis. Eur J Gastroenterol Hepatol 2019; 31:979-984. [PMID: 31149913 DOI: 10.1097/meg.0000000000001457] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
BACKGROUND Although surgical or endoscopic treatment is effective for pain control in symptomatic calcified chronic pancreatitis, it is still unknown whether early intervention in mild symptomatic pancreatic stones would reduce the frequency of acute exacerbation and improve long-term outcomes. The aim of this randomized-controlled trial was to explore the efficacy of early endotherapy for mild symptomatic pancreatic stones in comparison with the wait-and-see policy. MATERIALS AND METHODS Patients with mild symptoms because of pancreatic stones were assigned randomly to the endotherapy or the wait-and-see group. The wait-and-see group received endotherapy only when they developed refractory exacerbation or intractable pain. The primary outcome was the cumulative incidence of intolerable pain attacks and acute exacerbation. The secondary outcomes were the development of pancreatic insufficiency and the progression of pancreatic atrophy. RESULTS A total of 20 patients were enrolled between March 2008 and March 2011. The study was terminated prematurely because of the poor patient enrollment. Early endotherapy tended to reduce the cumulative incidence of pain attacks and exacerbation, (P=0.17) with the composite incidence of pain attacks and exacerbation of 30% in the endotherapy group and 60% in the wait-and-see group. There were no significant differences in terms of diabetic status and the presence of steatorrhea. The thickness of the pancreas decreased significantly in the wait-and-see group (9.2-6.8 mm, P=0.041), but not in the endotherapy group (8.7-9.0 mm, P=0.60). CONCLUSION In a small group of patients, early endotherapy in mild symptomatic chronic pancreatitis was associated with a trend toward a minor number of acute attacks and atrophy progression of the pancreas.
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Affiliation(s)
- Tomotaka Saito
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Suguru Mizuno
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University
| | - Naoki Sasahira
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research
| | - Takeo Watanabe
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology, Tokyo Takanawa Hospital
| | - Saburo Matsubara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
| | - Toshihiko Arizumi
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Medicine, Teikyo University School of Medicine
| | - Osamu Togawa
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology, Kanto Central Hospital, Tokyo
| | - Kenji Hirano
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
- Department of Gastroenterology, Tokyo Takanawa Hospital
| | - Takeshi Tsujino
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Kazunaga Ishigaki
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Ryunosuke Hakuta
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Kei Saito
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Naminatsu Takahara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Hirofumi Kogure
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Minoru Tada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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Layer P, Kashirskaya N, Gubergrits N. Contribution of pancreatic enzyme replacement therapy to survival and quality of life in patients with pancreatic exocrine insufficiency. World J Gastroenterol 2019; 25:2430-2441. [PMID: 31171887 PMCID: PMC6543241 DOI: 10.3748/wjg.v25.i20.2430] [Citation(s) in RCA: 39] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2019] [Revised: 04/02/2019] [Accepted: 04/20/2019] [Indexed: 02/06/2023] Open
Abstract
The objective of this study was to analyze the current evidence for the use of pancreatic enzyme replacement therapy (PERT) in affecting survival and quality of life in patients with pancreatic exocrine insufficiency (PEI). Systematic searches of the literature were performed using the PubMed database. Articles were selected for inclusion if they reported findings from trials assessing the effects of PERT on quality of life, survival, malabsorption, growth parameters (such as height, body weight and body mass index), or gastrointestinal symptoms (such as abdominal pain, stool consistency and flatulence). PERT improved PEI-related malabsorption and weight maintenance in patients with cystic fibrosis, chronic pancreatitis, pancreatic cancer, and post-surgical states. In patients with chronic pancreatitis, PERT improved PEI-related symptoms and quality of life measures. Several small retrospective studies have also suggested that PERT may have a positive impact on survival, but long-term studies assessing this effect were not identified. PERT is effective for treating malnutrition and supporting weight maintenance, and it is associated with improved quality of life and possibly with enhanced survival in patients with PEI. However, there is evidence that not all patients with PEI receive adequate PERT. Future work should aim to assess the long-term effects of PERT on the survival of patients with PEI.
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Affiliation(s)
- Peter Layer
- Department of Internal Medicine, Israelitic Hospital, Hamburg 22297, Germany
| | - Nataliya Kashirskaya
- Department of Genetic Epidemiology (Cystic Fibrosis group), Federal State Budgetary Institution “Research Centre for Medical Genetics”, Moscow 115522, Russia
| | - Natalya Gubergrits
- Department of Internal Medicine, Donetsk National Medical University, Lyman 83001, Ukraine
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Saito T, Nakai Y, Isayama H, Hirano K, Ishigaki K, Hakuta R, Takeda T, Saito K, Umefune G, Akiyama D, Watanabe T, Takagi K, Takahara N, Hamada T, Uchino R, Mizuno S, Mouri D, Yagioka H, Kogure H, Togawa O, Matsubara S, Ito Y, Yamamoto N, Tada M, Koike K. A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer. Pancreas 2018; 47:800-806. [PMID: 29851751 DOI: 10.1097/mpa.0000000000001079] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
OBJECTIVE Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients. METHODS Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival. RESULTS A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070). CONCLUSIONS In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.
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Affiliation(s)
| | | | | | - Kenji Hirano
- Department of Gastroenterology, Tokyo Takanawa Hospital
| | | | - Ryunosuke Hakuta
- Department of Gastroenterology, Japanese Red Cross Medical Center
| | | | | | | | - Dai Akiyama
- Department of Gastroenterology, JR Tokyo General Hospital
| | | | | | | | | | | | | | - Dai Mouri
- Department of Gastroenterology, Tokyo Takanawa Hospital
| | - Hiroshi Yagioka
- Department of Gastroenterology, Tokyo Metropolitan Police Hospital
| | | | - Osamu Togawa
- Department of Gastroenterology, Kanto Central Hospital
| | | | - Yukiko Ito
- Department of Gastroenterology, Japanese Red Cross Medical Center
| | - Natsuyo Yamamoto
- Department of Gastroenterology, Toshiba General Hospital, Tokyo, Japan
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Abstract
Malnutrition is a frequent complication in patients with chronic pancreatitis. Maldigestion as a consequence of pancreatic exocrine insufficiency is the major cause of malnutrition in these patients. Together with that, toxic habits and alterations of the gastroduodenal transit may play a relevant role. Malnutrition in chronic pancreatitis is associated with osteoporosis, sarcopenia, poor quality of life, and increased mortality. An adequate nutritional evaluation including anthropometric, biochemical, and morphologic parameters is recommended in these patients. Nutritional advice and support together with an adequate pancreatic enzyme replacement therapy are indicated.
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Durie P, Baillargeon JD, Bouchard S, Donnellan F, Zepeda-Gomez S, Teshima C. Diagnosis and management of pancreatic exocrine insufficiency (PEI) in primary care: consensus guidance of a Canadian expert panel. Curr Med Res Opin 2018; 34:25-33. [PMID: 28985688 DOI: 10.1080/03007995.2017.1389704] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND Pancreatic exocrine insufficiency (PEI) results in maldigestion due to inadequate activity of pancreatic enzymes in the small bowel. PEI can arise from a variety of medical conditions that reduce enzyme synthesis within the pancreatic parenchyma or from secondary factors that may occur despite optimal parenchymal function, such as pancreatic duct obstruction or impaired or poorly synchronized enzyme release. PURPOSE To provide practical guidance for primary care physicians managing patients who are at risk of PEI or who present with symptoms of PEI. METHODS For each of six key clinical questions identified by the authors, PubMed searches were conducted to identify key English-language papers up to April 2017. Forward and backward searches on key articles were conducted using Web of Science. Clinical recommendations proposed by the co-chairs (P.D. and C.T.) were vetted and approved based on the authors? FINDINGS The most characteristic symptom of PEI is steatorrhea ? voluminous, lipid-rich stools; other common signs and symptoms include unexplained weight loss and deficiencies of fat-soluble vitamins and other micronutrients. Pancreatic enzyme replacement therapy (PERT) can relieve symptoms and long-term sequelae of PEI. Diagnosis of PEI and initiation of PERT are usually the responsibility of gastroenterology specialists. However, primary care physicians (PCPs) are well positioned to identify potential cases of PEI and to participate in the collaborative, long-term management of patients already seen by a specialist. CONCLUSIONS In this document, a panel of Canadian gastroenterologists has conducted a critical review of the literature on PEI and PERT and has developed practical diagnostic and treatment recommendations for PCPs. These recommendations provide guidance on identifying patients at risk of PEI, the triggers for PEI testing and referral, and best practices for co-managing patients with confirmed PEI.
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Affiliation(s)
- P Durie
- a Hospital for Sick Children and University of Toronto , Toronto , ON , Canada
| | - J-D Baillargeon
- b Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke , Sherbrooke , QC , Canada
| | - S Bouchard
- c Centre Hospitalier de l'Université de Montréal , Montréal , QC , Canada
| | - F Donnellan
- d Vancouver General Hospital , Vancouver , BC , Canada
| | | | - C Teshima
- f St. Michael's Hospital and University of Toronto , Toronto , ON , Canada
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Nishiyama H, Nagai T, Kudo M, Okazaki Y, Azuma Y, Watanabe T, Goto S, Ogata H, Sakurai T. Supplementation of pancreatic digestive enzymes alters the composition of intestinal microbiota in mice. Biochem Biophys Res Commun 2017; 495:273-279. [PMID: 29106956 DOI: 10.1016/j.bbrc.2017.10.130] [Citation(s) in RCA: 44] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2017] [Accepted: 10/25/2017] [Indexed: 02/06/2023]
Abstract
Although pancreatic enzyme replacement therapy (PERT) is effective in the alleviation of pancreatic exocrine insufficiency (PEI)-related symptoms in patients with chronic pancreatitis, its mechanism of action is poorly understood. Recent studies suggest that the intestinal microbiota is associated with the pathogenesis of chronic pancreatitis. Therefore, we hypothesized that PERT exerts its effect by modifying the intestinal microbiota in addition to its presumed role in promoting fat and protein absorption. To explore the mechanism of action of PERT, we analyzed the intestinal microbiotas of two groups of mice treated with either pancrelipase or tap water by using 16S rRNA amplicon sequencing. The results revealed that the bacterial compositions of the pancrelipase-treated mice were significantly different from those of the control samples. Akkermansia muciniphila, a key beneficial bacterium in the intestinal tract, showed a higher relative abundance in the pancrelipase-treated samples than in the control samples. Lactobacillus reuteri, a widely used probiotic bacterium known to relieve intestinal inflammation, also showed a higher relative abundance in the pancrelipase-treated samples. These results suggested that PERT induces the colonization of beneficial bacteria, thereby contributing to the attenuation of PEI-associated symptoms in addition to improvement of the nutritional state.
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Affiliation(s)
- Hiroki Nishiyama
- Institute for Chemical Research, Kyoto University, Gokasho, Uji, Kyoto 611-0011, Japan
| | - Tomoyuki Nagai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
| | - Yoshihisa Okazaki
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
| | - Yoshinao Azuma
- Biology-Oriented Science and Technology, Kindai University, 930 Nishimitani, Kinokawa, Wakayama 649-6493, Japan
| | - Tomohiro Watanabe
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
| | - Susumu Goto
- Database Center for Life Science, Joint Support-Center for Data Science Research, Research Organization of Information and Systems, 178-4-4 Wakashiba, Kashiwa, Chiba 277-0871, Japan
| | - Hiroyuki Ogata
- Institute for Chemical Research, Kyoto University, Gokasho, Uji, Kyoto 611-0011, Japan.
| | - Toshiharu Sakurai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.
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Singh VK, Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol 2017; 23:7059-7076. [PMID: 29093615 PMCID: PMC5656454 DOI: 10.3748/wjg.v23.i39.7059] [Citation(s) in RCA: 90] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2016] [Revised: 05/27/2017] [Accepted: 06/01/2017] [Indexed: 02/06/2023] Open
Abstract
Exocrine pancreatic insufficiency (EPI), an important cause of maldigestion and malabsorption, results from primary pancreatic diseases or secondarily impaired exocrine pancreatic function. Besides cystic fibrosis and chronic pancreatitis, the most common etiologies of EPI, other causes of EPI include unresectable pancreatic cancer, metabolic diseases (diabetes); impaired hormonal stimulation of exocrine pancreatic secretion by cholecystokinin (CCK); celiac or inflammatory bowel disease (IBD) due to loss of intestinal brush border proteins; and gastrointestinal surgery (asynchrony between motor and secretory functions, impaired enteropancreatic feedback, and inadequate mixing of pancreatic secretions with food). This paper reviews such conditions that have less straightforward associations with EPI and examines the role of pancreatic enzyme replacement therapy (PERT). Relevant literature was identified by database searches. Most patients with inoperable pancreatic cancer develop EPI (66%-92%). EPI occurs in patients with type 1 (26%-57%) or type 2 diabetes (20%-36%) and is typically mild to moderate; by definition, all patients with type 3c (pancreatogenic) diabetes have EPI. EPI occurs in untreated celiac disease (4%-80%), but typically resolves on a gluten-free diet. EPI manifests in patients with IBD (14%-74%) and up to 100% of gastrointestinal surgery patients (47%-100%; dependent on surgical site). With the paucity of published studies on PERT use for these conditions, recommendations for or against PERT use remain ambiguous. The authors conclude that there is an urgent need to conduct robust clinical studies to understand the validity and nature of associations between EPI and medical conditions beyond those with proven mechanisms, and examine the potential role for PERT.
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Affiliation(s)
- Vikesh K Singh
- Division of Gastroenterology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, United States
| | - Mark E Haupt
- Medical Affairs, AbbVie Inc., North Chicago, IL 60064, United States
| | - David E Geller
- Cystic Fibrosis Clinical Development, AbbVie Inc., North Chicago, IL 60064, United States
| | - Jerry A Hall
- CREON® Clinical Development, AbbVie Inc., North Chicago, IL 60064, United States
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Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study. GASTROENTEROLOGIA Y HEPATOLOGIA 2017; 41:77-86. [PMID: 28935122 DOI: 10.1016/j.gastrohep.2017.08.002] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/30/2017] [Revised: 06/20/2017] [Accepted: 08/08/2017] [Indexed: 02/08/2023]
Abstract
BACKGROUND/OBJECTIVES Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). METHODS This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. RESULTS 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0μg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). CONCLUSIONS Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL.
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Nikfarjam M, Wilson JS, Smith RC. Diagnosis and management of pancreatic exocrine insufficiency. Med J Aust 2017; 207:161-165. [PMID: 28814218 DOI: 10.5694/mja16.00851] [Citation(s) in RCA: 35] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2016] [Accepted: 12/12/2016] [Indexed: 12/11/2022]
Abstract
In 2015, the Australasian Pancreatic Club (APC) published the Australasian guidelines for the management of pancreatic exocrine insufficiency (http://pancreas.org.au/2016/01/pancreatic-exocrine-insufficiency-guidelines). Pancreatic exocrine insufficiency (PEI) occurs when normal digestion cannot be sustained due to insufficient pancreatic digestive enzyme activity. This may be related to a breakdown, at any point, in the pancreatic digestive chain: pancreatic stimulation; synthesis, release or transportation of pancreatic enzymes; or synchronisation of secretions to mix with ingested food. Main recommendations: The guidelines provide advice on diagnosis and management of PEI, noting the following: A high prevalence of PEI is seen in certain diseases and conditions, such as cystic fibrosis, acute and chronic pancreatitis, pancreatic cancer and pancreatic surgery. The main symptoms of PEI are steatorrhoea or diarrhoea, abdominal pain, bloating and weight loss. These symptoms are non-specific and often go undetected and untreated. PEI diagnosis is predominantly based on clinical findings and the presence of underlying disease. The likelihood of PEI in suspected patients has been categorised into three groups: definite, possible and unlikely. If left untreated, PEI may lead to complications related to fat malabsorption and malnutrition, and have an impact on quality of life. Pancreatic enzyme replacement therapy (PERT) remains the mainstay of PEI treatment with the recommended adult initial enzyme dose being 25 000-40 000 units of lipase per meal, titrating up to a maximum of 75 000-80 000 units of lipase per meal. Adjunct acid-suppressing therapy may be useful when patients still experience symptoms of PEI on high dose PERT. Nutritional management by an experienced dietitian is essential. Changes in management as a result of these guidelines: These are the first guidelines to classify PEI as being definite, possible or unlikely, and provide a diagnostic algorithm to facilitate the early diagnosis of PEI and appropriate use of PERT.
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Affiliation(s)
| | - Jeremy S Wilson
- South Western Sydney Clinical School, Liverpool Hospital, UNSW, Sydney, NSW
| | - Ross C Smith
- Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, NSW
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de la Iglesia-García D, Huang W, Szatmary P, Baston-Rey I, Gonzalez-Lopez J, Prada-Ramallal G, Mukherjee R, Nunes QM, Domínguez-Muñoz JE, Sutton R, NIHR Pancreas Biomedical Research Unit Patient Advisory Group. Efficacy of pancreatic enzyme replacement therapy in chronic pancreatitis: systematic review and meta-analysis. Gut 2017; 66:1354-1355. [PMID: 27941156 PMCID: PMC5530474 DOI: 10.1136/gutjnl-2016-312529] [Citation(s) in RCA: 108] [Impact Index Per Article: 13.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2016] [Revised: 11/06/2016] [Accepted: 11/18/2016] [Indexed: 02/05/2023]
Abstract
OBJECTIVE The benefits of pancreatic enzyme replacement therapy (PERT) in chronic pancreatitis (CP) are inadequately defined. We have undertaken a systematic review and meta-analysis of randomised controlled trials of PERT to determine the efficacy of PERT in exocrine pancreatic insufficiency (EPI) from CP. DESIGN Major databases were searched from 1966 to 2015 inclusive. The primary outcome was coefficient of fat absorption (CFA). Effects of PERT versus baseline and versus placebo, and of different doses, formulations and schedules were determined. RESULTS A total of 17 studies (511 patients with CP) were included and assessed qualitatively (Jadad score). Quantitative data were synthesised from 14 studies. PERT improved CFA compared with baseline (83.7±6.0 vs 63.1±15.0, p<0.00001; I2=89%) and placebo (83.2±5.5 vs 67.4±7.0, p=0.0001; I2=86%). PERT improved coefficient of nitrogen absorption, reduced faecal fat excretion, faecal nitrogen excretion, faecal weight and abdominal pain, without significant adverse events. Follow-up studies demonstrated that PERT increased serum nutritional parameters, improved GI symptoms and quality of life without significant adverse events. High-dose or enteric-coated enzymes showed a trend to greater effectiveness than low-dose or non-coated comparisons, respectively. Subgroup, sensitive and meta-regression analyses revealed that sample size, CP diagnostic criteria, study design and enzyme dose contributed to heterogeneity; data on health inequalities were lacking. CONCLUSIONS PERT is indicated to correct EPI and malnutrition in CP and may be improved by higher doses, enteric coating, administration during food and acid suppression. Further studies are required to determine optimal regimens, the impact of health inequalities and long-term effects on nutrition.
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Affiliation(s)
- Daniel de la Iglesia-García
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK,Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Compostela, Spain
| | - Wei Huang
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK,Department of Integrated Traditional Chinese and Western Medicine, Sichuan Provincial Pancreatitis Centre, West China Hospital, Sichuan University, Chengdu, China
| | - Peter Szatmary
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK
| | - Iria Baston-Rey
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Compostela, Spain
| | - Jaime Gonzalez-Lopez
- Department of Pharmacy, University Hospital of Santiago de Compostela, Compostela, Spain
| | - Guillermo Prada-Ramallal
- Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Compostela, Spain
| | - Rajarshi Mukherjee
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK
| | - Quentin M Nunes
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK
| | - J Enrique Domínguez-Muñoz
- Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Compostela, Spain
| | - Robert Sutton
- NIHR Liverpool Pancreas Biomedical Research Unit, Royal Liverpool University Hospital, University of Liverpool, Liverpool, UK
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González-Sánchez V, Amrani R, González V, Trigo C, Picó A, de-Madaria E. Diagnosis of exocrine pancreatic insufficiency in chronic pancreatitis: 13C-Mixed Triglyceride Breath Test versus Fecal Elastase. Pancreatology 2017; 17:580-585. [PMID: 28291656 DOI: 10.1016/j.pan.2017.03.002] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/02/2017] [Revised: 03/01/2017] [Accepted: 03/05/2017] [Indexed: 02/07/2023]
Abstract
BACKGROUND Pancreatic enzyme replacement therapy (PERT) is indicated in case of clinically relevant exocrine pancreatic insufficiency (EPI). Clinical trials addressing PERT have used the coefficient of fat absorption (CFA) to define EPI but this test is cumbersome to perform. Our aim was to compare two easier-to-perform tests to detect clinically relevant EPI: Fecal Elastase-1 (FE-1) and 13C-Mixed Triglyceride Breath Test (TGBT). METHODS We prospectively included 54 patients with chronic pancreatitis (CP), 24.1% operated, 29.6% had EPI. EPI was defined as a CFA <93%. The sensitivity (Se), specificity (Sp), positive (PPV) and negative (NPV) predictive values for different cut-offs of FE-1 and TGBT were calculated. RESULTS The area under the ROC curve for FE-1/TGBT was 0.861/0.876 for the global sample, 0.842/0.794 for non-operated patients and 0.917/1 for operated patients respectively. Se, Sp, PPV and NPV for a cut-off of FE-1 <200 μg/g were 93.8%, 63.2%, 51.7% and 96% respectively. The best cut-off point for FE-1 was 84 μg/g, which yielded an 87.5% Se, 81.6% Sp, 66.7% PPV and 93.9% NPV. The same parameters for a TGBT <29% were 81.3%, 84.2%, 68.4% and 91.4% respectively. The best cut-off point for TGBT was <23%, which yielded an 81.3% Se, 94.7% Sp, 86.7% PPV and 92.3% NPV. Diabetes was associated to decreased FE-1 levels, even in multivariate analysis. CONCLUSIONS FE-1 and TGBT showed similar results for the diagnosis of EPI in CP. In non-operated CP patients, TGBT does not offer any advantage to FE-1 but in operated CP patients TGBT seems a more accurate test.
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Affiliation(s)
- Víctor González-Sánchez
- Sección de Endocrinología y Nutrición, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain
| | - Rahma Amrani
- Sección de Endocrinología y Nutrición, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain
| | - Victoria González
- Servicio de Análisis Clínicos, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain
| | - Celia Trigo
- Servicio de Análisis Clínicos, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain
| | - Antonio Picó
- Sección de Endocrinología y Nutrición, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain
| | - Enrique de-Madaria
- Servicio de Gastroenterología, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain.
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Abstract
AIM AND OBJECTIVES Exocrine pancreatic insufficiency caused by inflammation or pancreatic tumors results in nutrient malfunction by a lack of digestive enzymes and neutralization compounds. Despite satisfactory clinical results with current enzyme therapies, a normalization of fat absorption in patients is rare. An individualized therapy is required that includes high dosage of enzymatic units, usage of enteric coating, and addition of gastric proton pump inhibitors. The key goal to improve this therapy is to identify digestive enzymes with high activity and stability in the gastrointestinal tract. METHODS We cloned and analyzed three novel ciliate lipases derived from Tetrahymena thermophila. Using highly precise pH-STAT-titration and colorimetric methods, we determined stability and lipolytic activity under physiological conditions in comparison with commercially available porcine and fungal digestive enzyme preparations. We measured from pH 2.0 to 9.0, with different bile salts concentrations, and substrates such as olive oil and fat derived from pig diet. RESULTS Ciliate lipases CL-120, CL-130, and CL-230 showed activities up to 220-fold higher than Creon, pancreatin standard, and rizolipase Nortase within a pH range from pH 2.0 to 9.0. They are highly active in the presence of bile salts and complex pig diet substrate, and more stable after incubation in human gastric juice compared with porcine pancreatic lipase and rizolipase. CONCLUSIONS The newly cloned and characterized lipases fulfilled all requirements for high activity under physiological conditions. These novel enzymes are therefore promising candidates for an improved enzyme replacement therapy for exocrine pancreatic insufficiency.
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Abstract
OBJECTIVES Smoking is a known risk factor for developing chronic pancreatitis and accelerates disease progression. Smoking cessation remains an important treatment recommendation, but little is known about its effects. This study evaluated smoking cessation in this population and its impact on quality of life. METHODS Twenty-seven smokers with chronic pancreatitis participated in a smoking cessation program incorporating the QuitWorks program and individual counseling. Their smoking cessation rates were compared with a control population (n = 200) consisting of inpatients without chronic pancreatitis who smoked. Smokers were also compared with nonsmokers (n = 25) with chronic pancreatitis in terms of quality-of-life indicators. RESULTS In 27 patients, 0 had quit smoking at 6 months, 1 at 12 months, and 0 patients at 18 months. There was a 19% quit rate in the control population at the 6-month period. Smokers had a worse quality of life, higher rates of depression and anxiety, and worse coping skills than nonsmokers. CONCLUSIONS Smoking cessation in the chronic pancreatitis population is extremely challenging, as shown by our 0% quit rate after 18 months. Given that smokers with chronic pancreatitis also experience a worse quality of life, it becomes even more important to stress the importance of smoking cessation in these patients.
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