Indomethacin with or without Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis after ERCP: A Randomised Non-Inferiority Trial
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Le résumé fourni par la source
BACKGROUND: The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention. METHODS: In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete. FINDINGS: Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups. INTERPRETATION: For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines. FUNDING: US National Institutes of Health.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Indomethacin with or without Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis after ERCP: A Randomised Non-Inferiority Trial
- Date Crossref
- 28/07/2026
- Éditeur
- CRC Press
- Type
- book-chapter
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Medical University of South Carolina Division of Gastroenterology & Hepatology pays non établi dans la noticeUniversité ou école supérieure
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National Institutes of Health pays non établi dans la noticeOrganisme public
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National Institute of Diabetes and Digestive and Kidney Diseases pays non établi dans la noticeStructure de recherche
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Oregon Health & Science University Division of Gastroenterology & Hepatology pays non établi dans la noticeUniversité ou école supérieure
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University of Colorado Anschutz Division of Gastroenterology and Hepatology pays non établi dans la noticeUniversité ou école supérieure
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Johns Hopkins University pays non établi dans la noticeUniversité ou école supérieure
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University of Michigan Division of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Emory University Division of Digestive Diseases pays non établi dans la noticeUniversité ou école supérieure
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The Ohio State University Wexner Medical Center and Nutrition pays non établi dans la noticeÉtablissement de santé
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University Hospitals of Cleveland pays non établi dans la noticeÉtablissement de santé
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University of Pittsburgh Medical Center and Nutrition pays non établi dans la noticeÉtablissement de santé
Division of Gastroenterology & Hepatology — Medical University of South Carolina, National Institutes of Health et National Institute of Diabetes and Digestive and Kidney Diseases, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.