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Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients.
Gastroenterology. 2016 Apr; 150(4):911-7; quiz e19.G

Abstract

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.

Authors+Show Affiliations

Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Section of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. Electronic address: jlevenick@hmc.psu.edu.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Investigational Pharmacy, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26775631

Citation

Levenick, John M., et al. "Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients." Gastroenterology, vol. 150, no. 4, 2016, pp. 911-7; quiz e19.
Levenick JM, Gordon SR, Fadden LL, et al. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016;150(4):911-7; quiz e19.
Levenick, J. M., Gordon, S. R., Fadden, L. L., Levy, L. C., Rockacy, M. J., Hyder, S. M., Lacy, B. E., Bensen, S. P., Parr, D. D., & Gardner, T. B. (2016). Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology, 150(4), 911-7; quiz e19. https://doi.org/10.1053/j.gastro.2015.12.040
Levenick JM, et al. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016;150(4):911-7; quiz e19. PubMed PMID: 26775631.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. AU - Levenick,John M, AU - Gordon,Stuart R, AU - Fadden,Linda L, AU - Levy,L Campbell, AU - Rockacy,Matthew J, AU - Hyder,Sarah M, AU - Lacy,Brian E, AU - Bensen,Steven P, AU - Parr,Douglas D, AU - Gardner,Timothy B, Y1 - 2016/01/09/ PY - 2015/07/02/received PY - 2015/12/23/revised PY - 2015/12/27/accepted PY - 2016/1/19/entrez PY - 2016/1/19/pubmed PY - 2016/8/9/medline KW - ESGE Recommendation KW - Inflammation KW - NSAID KW - Pancreas SP - 911-7; quiz e19 JF - Gastroenterology JO - Gastroenterology VL - 150 IS - 4 N2 - 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/26775631/Rectal_Indomethacin_Does_Not_Prevent_Post_ERCP_Pancreatitis_in_Consecutive_Patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(16)00004-4 DB - PRIME DP - Unbound Medicine ER -