Role of Rectal Diclofenac Suppository for Prevention and Its Impact on Severity of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-Risk Patients

BACKGROUND The aim was to study the role of rectal diclofenac in prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis and its impact on severity of post-ERCP pancreatitis. METHODS We conducted a single-center, prospective, open-labeled, randomized trial for evaluating the use of rectal diclofenac in prevention of post-ERCP pancreatitis in high-risk patients. We assessed 526 patients coming for ERCP for different indications. Four hundred patients were eligible for the study. Those not fitting the high-risk criteria and with acute pancreatitis were excluded. These patients were randomized in two groups: 200 patients received rectal diclofenac prior to or during the procedure, while 200 patients received placebos. Serum amylase was measured at 2 and 36 hours. Post-ERCP pancreatitis was defined as serum amylase > 3 times upper limit of normal with associated severe abdominal pain. Severity was graded according to days of hospitalization and complications. RESULTS Twenty-nine out of 400 (7.2%) patients developed post-ERCP pancreatitis. Six out of 200 (3%) patients in rectal diclofenac group developed post-ERCP pancreatitis compared to 23 out of 200 (11.5%) patients in placebo group. The difference was statistically significant (P = 0.001). All patients (six) in rectal diclofenac group developed mild pancreatitis as compared to severe pancreatitis in four and moderate pancreatitis in five patients in the placebo group. CONCLUSION Rectal diclofenac prior to or during ERCP in high-risk patients reduces the incidence as well as severity of post-ERCP pancreatitis compared to placebo.