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Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: A double-blind, randomised controlled trial

The Lancet: Gastroenterology & Hepatology Dec 08, 2019

Fogel EL, Lehman GA, Tarnasky P, et al. - Researchers performed this randomised, double-blind, comparative effectiveness trial, to compare two dose regimens of rectal indometacin in terms of efficacy on the frequency and severity of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Participants were recruited from six tertiary medical centres in the USA. This inquiry was performed in patients at a high risk of developing pancreatitis post-ERCP. Shortly after ERCP, the random allocation of eligible patients (1:1) was done to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). An additional 50 mg indometacin suppository and an additional placebo suppository was administered to patients assigned to the high-dose group and patients in the standard-dose group, respectively, at 4 h after the procedure. Findings revealed no benefit of dose escalation to rectal indometacin 200 mg vs the standard 100 mg regimen, and the reported incidence of pancreatitis continued to be high in high-risk patients. In view of these findings, current practice should continue unchanged.
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