Prophylactic Effect of Rectal Indomethacin Administration, with and without Intravenous Hydration, on Development of Endoscopic Retrograde Cholangiopancreatography Pancreatitis Episodes: A Randomized Clinical Trial

Background Acute Post ERCP Pancreatitis (PEP) is the most common major complication of Endoscopic retrograde cholangiopancreatography (ERCP). The aim of the current study was to assess the utility of single dose rectal indomethacin with and without intravenous perfusion of normal saline to prevent acute pancreatitis. Methods In this randomized clinical trial, 406 patients with choledocolithiasis underwent ERCP. Based on computer-generated numbers, the patients were allocated into 4 groups, each group receiving a different intervention prior to the ERCP procedure. The interventions included rectal indomethacin (100mg) in the first group, intravenous (IV) saline perfusion in the second, both rectal indomethacin and IV saline in the third, and the fourth (control) group receiving rectal glycerin. Serum amylase levels were measured and clinical pancreatitis episodes were quantified and classified according to APACHE II prognostic criteria. Statistical inference was performed using the chi-square or Fisher’s exact test for qualitative variables, while Student’s zxA-test was used for quantitative variables. Results A diagnosis of mild pancreatitis was present in 38 (9.4%) cases. The numbers of events in the four study groups were 11, 10, 0, and 17, respectively, corresponding to an absolute risk reduction of 5.2% , 6.2%, 16.2% (number needed to prevent one episode of PEP) and a relative risk reduction of 32%, 38% and 100% in the three study groups, respectively. The frequency of PEP was only significant in the third group (P 0.001). Conclusions The combination of rectal indomethacin and intravenous normal saline before ERCP significantly prevents post-ERCP pancreatitis.