Abstract
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.