Administration of Rectal Diclofenac before, Compared with before-after Endoscopic Retrograde Cholangiopancreatography to Prevent Pancreatitis; a Double-Blind Randomized Controlled Trial

Abstract

Background:

 Acute pancreatitis is one of the most common complications following endoscopic retrograde cholangiopancreatography (ERCP), which can be life-threatening if the treatment is postponed. This study aimed to evaluate the effect of non-steroidal anti-inflammatory drugs (suppository diclofenac) on preventing post-ERCP pancreatitis (PEP).

Materials and Methods:

 In this double-blind, randomized clinical trial, 219 patients referred to our ERCP unit who passed inclusion and exclusion criteria were randomly assigned to two groups: group A (103 patients) received a diclofenac suppository 30 minutes before and immediately after ERCP. In Group B (116 patients), a diclofenac suppository was prescribed only before the procedure. Patients were evaluated regarding clinical signs and symptoms of pancreatitis for 24 hours. Also, serum amylase level was checked at baseline, 6, and 24 hours after the procedure.

The study protocol was approved by the Ethics Committee of the Iran University of Medical Sciences (IR.IUMS.FMD.REC.1399.190). Also, the study protocol was registered in the Iranian Registry for Clinical Trials (IRCT20191231045969N2).

Results:

The PEP was seen in three patients in group A and seven patients in group B, which was not significantly different (P=0.341). The severity of pancreatitis was mild in all patients except one in group B, who developed moderate PEP. Moreover, in 97.71 % of cases, ERCP was successful for the first time, and in 94.18 % of group A and 89.66% of group B, no complications of bleeding or perforation were detected.

Conclusion:

Administration of rectal diclofenac before and after ERCP had no significant effect on the prevention of pancreatitis compared with pre-ERCP administration.