Rectal INdomethacin, oral TacROlimus, or their combination for the prevention of post-ERCP pancreatitis (INTRO Trial): Protocol for a randomized, controlled, double-blinded trial
| العنوان: | Rectal INdomethacin, oral TacROlimus, or their combination for the prevention of post-ERCP pancreatitis (INTRO Trial): Protocol for a randomized, controlled, double-blinded trial |
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| المؤلفون: | Venkata S. Akshintala, Sohail Z. Husain, Todd A. Brenner, Anmol Singh, Vikesh K. Singh, Mouen A. Khashab, Christina J. Sperna Weiland, Erwin J.M. van Geenen, Nikhil Bush, Monique Barakat, Ananta Srivastava, Rakesh Kochhar, Rupjyoti Talukdar, Gajanan Rodge, Clement C.H. Wu, Sundeep Lakhtakia, Saroj K. Sinha, Mahesh K. Goenka, D. Nageshwar Reddy |
| المصدر: | Pancreatology, 22, 7, pp. 887-893 Pancreatology, 22, 887-893 |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Cholangiopancreatography, Endoscopic Retrograde, Hepatology, Endocrinology, Diabetes and Metabolism, Indomethacin, Calcineurin Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Gastroenterology, Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0], Tacrolimus, Pancreatitis, Administration, Rectal, Acute Disease, Humans, Multicenter Studies as Topic, Retrospective Studies, Randomized Controlled Trials as Topic |
| الوصف: | Item does not contain fulltext BACKGROUND: Acute pancreatitis remains the most common and morbid complication of endoscopic retrograde cholangiopancreatography (ERCP). The use of rectal indomethacin and pancreatic duct stenting has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP), but these interventions have limitations. Recent clinical and translational evidence suggests a role for calcineurin inhibitors in the prevention of pancreatitis, with multiple retrospective case series showing a reduction in PEP rates in tacrolimus users. METHODS: The INTRO trial is a multicenter, international, randomized, double-blinded, controlled trial. A total of 4,874 patients undergoing ERCP will be randomized to receive either oral tacrolimus (5 mg) or oral placebo 1-2 h before ERCP, and followed for 30 days post-procedure. Blood and pancreatic aspirate samples will also be collected in a subset of patients to quantify tacrolimus levels. The primary outcome of the study is the incidence of PEP. Secondary endpoints include the severity of PEP, ERCP-related complications, adverse drug events, length of hospital stay, cost-effectiveness, and the pharmacokinetics, pharmacodynamics, and pharmacogenomics of tacrolimus immune modulation in the pancreas. CONCLUSIONS: The INTRO trial will assess the role of calcineurin inhibitors in PEP prophylaxis and develop a foundation for the clinical optimization of this therapeutic strategy from a pharmacologic and economic standpoint. With this clinical trial, we hope to demonstrate a novel approach to PEP prophylaxis using a widely available and well-characterized class of drugs. TRIAL REGISTRATION: NCT05252754, registered on February 14, 2022. 01 november 2022 |
| تدمد: | 1424-3903 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5be6ef09785aa5388b2a1334ad06ac53Test https://repository.ubn.ru.nl/handle/2066/288036Test |
| حقوق: | RESTRICTED |
| رقم الانضمام: | edsair.doi.dedup.....5be6ef09785aa5388b2a1334ad06ac53 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14243903 |
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