Gastroenterology

Gastroenterology

Volume 150, Issue 4, April 2016, Pages 911-917
Gastroenterology

Original Research
Full Report: Clinical—Pancreas
Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients

https://doi.org/10.1053/j.gastro.2015.12.040Get rights and content

Background & Aims

Rectal indomethacin, a nonsteroidal anti-inflammatory drug, is given to prevent pancreatitis in high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), based on findings from clinical trials. The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP, including those at average risk for pancreatitis. We performed a randomized controlled trail to investigate the efficacy of this approach.

Methods

We performed a prospective, double-blind, placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center, from March 2013 through December 2014. Approximately 70% of the cohort were at average risk for PEP. Subjects were assigned randomly to groups given either a single 100-mg dose of rectal indomethacin (n = 223) or a placebo suppository (n = 226) during the procedure. The primary outcome was the development of post-ERCP pancreatitis (PEP), defined by new upper-abdominal pain, a lipase level more than 3-fold the upper limit of normal, and hospitalization after ERCP for 2 consecutive nights.

Results

There were no differences between the groups in baseline clinical or procedural characteristics. Sixteen patients in the indomethacin group (7.2%) and 11 in the placebo group (4.9%) developed PEP (P = .33). Complications and the severity of PEP were similar between groups. Per a priori protocol guidelines, the study was stopped owing to futility.

Conclusions

In a randomized controlled study of consecutive patients undergoing ERCP, rectal indomethacin did not prevent post-ERCP pancreatitis. ClincialTrials.gov no: NCT01774604.

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.).

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