April 16, 2012
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Rectally administered indomethacin prevented post-ERCP pancreatitis

One dose of rectal indomethacin can prevent pancreatitis after endoscopic retrograde cholangiopancreatography among high-risk patients, according to recent results.

The multicenter, randomized, double blind trial included 602 patients at high risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Participants enrolled from February 2009 through July 2011 and received one dose of rectal indomethacin (n=295) or placebo (n=307) immediately following ERCP to determine whether the treatment would prevent the onset of pancreatitis. Across both groups, 82% of participants had a clinical suspicion of sphincter of Oddi dysfunction.

In the indomethacin group, 27 patients (9.2%) developed post-ERCP pancreatitis, compared with 52 patients (16.9%) in the placebo group (P=.005). Pancreatitis was considered moderate-to-severe in 13 patients (4.4%) who received indomethacin and 27 patients (8.8%) who received placebo (P=.03). Patients in the indomethacin group also had shorter hospital stays than the placebo group (median 3.5 days vs. 4.0 days, P<.001). Response to the drug was not negatively influenced by sphincter of Oddi dysfunction or pancreatic stenting.

Researchers recorded 13 adverse events, including gastrointestinal bleeding in 11 patients (1.8%), with four participants in the indomethacin group and seven in the placebo group experiencing the symptom (P=.72). Acute renal failure occurred in two placebo group members.

“Our findings showed that one dose of rectal indomethacin given immediately after ERCP significantly reduced the incidence of post-ERCP pancreatitis in patients at elevated risk for this complication,” the researchers wrote. “Moreover, we found that prophylactic indomethacin decreased the severity of post-ERCP pancreatitis and was associated with a shorter hospital stay.”