1. Post-ERCP pancreatitis was more common in the indomethacin alone group compared to indomethacin plus stent group.

2. The benefit of stent placement was prominent among patients at high risk for pancreatitis.

Evidence Rating Level: 1 (Excellent)

Study Rundown: In high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), combining rectal indomethacin with prophylactic pancreatic stent placement is a recommended strategy to prevent pancreatitis. This randomized controlled trial aimed to assess the efficacy of indomethacin alone versus the combination of indomethacin plus stent placement. The primary outcome was the occurrence of post-ERCP pancreatitis, while key secondary outcomes were safety measures including serious adverse events and hospital length of stay. According to study results, the combination strategy was superior to indomethacin alone, with a lower incidence of post-ERCP pancreatitis. Although this study was well done, it was limited by the potential for unmeasured confounders influencing the results.

Click to read the study in The Lancet

Relevant Reading: A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

In-depth [randomized-controlled trial]: Between Sept 17, 2015, and Jan 25, 2023, 7243 patients were assessed for eligibility across 20 referral centers in Canada and the USA. Included were patients aged ≥ 18 years deemed at high risk for post-ERCP pancreatitis. Altogether, 1728 patients (777 in indomethacin plus stent and 951 in indomethacin alone) were included in the final analysis. The primary outcome of post-ERCP pancreatitis was more common in the indomethacin alone group compared to indomethacin plus stent group (14.9% vs. 11.3%, risk difference 3.6%, 95% confidence interval [CI] 0.6-6.6, p=0.18). The secondary outcome of safety measures did not differ between the two groups. Overall, findings from this study suggest that prophylactic pancreatic stent placement alongside rectal indomethacin is superior to indomethacin alone in preventing post-ERCP pancreatitis in high-risk patients.

Image: PD

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