Original ResearchFull Report: Clinical—PancreasRectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients
Section snippets
Study Design
We enrolled patients at a single tertiary-care academic medical center in the United States after approval from the Committee for the Protection of Human Subjects (Institutional Review Board [IRB]) at Dartmouth-Hitchcock Medical Center (CPHS#23749). An independent data and safety monitoring board provided regulatory oversight by reviewing blinded subject data, analyzing complications, and performing scheduled in-term analysis. The study was designed under the auspices of the Consolidated
Patients
From March 2013 to December 2014, all patients undergoing ERCP at our institution were screened for eligibility and offered inclusion into the study if eligible (Figure 1). A total of 449 patients eventually were enrolled in the study. In May 2014, the data and safety monitoring committee evaluated the first 350 patients and, as a result of indomethacin’s lack of efficacy, recommended continued enrollment with 75 more patients randomized. In December 2014, the board recommended termination of
Discussion
Our findings show that giving a single 100-mg dose of rectal indomethacin in consecutive individuals undergoing ERCP does not prevent PEP. These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP in high-risk patients.8 In addition, our results counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP.9
This study did
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This article has an accompanying continuing medical education activity on page e19. Learning Objective: Upon completion of this test, successful learners will be able to: (1) define post-ERCP pancreatitis; (2) discuss the efficacy of rectal indomethacin to prevent post-ERCP pancreatitis; (3) identify risk of UGI bleeding among ERCP patients given rectal indomethacin.
Conflicts of interest The authors disclose no conflicts.
Funding The National Pancreas Foundation supported the cost of the medications; this study also was supported in part by National Institutes of Health grant 1K23DK088832 (T.B.G.).