Is the Combination of Rectal Diclofenac and Intravenous Ringer Lactate Superior to Individual Therapy for Prophylaxis of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Prospective, Open-Label, Single-Center Randomized Trial.

ABSTRACT

METHODS: This was single-center, open-label, randomized trial. Patients who were undergoing ERCP and who were at high risk for the development of PEP were selected for the study. Patients were randomized into 3 treatment groups diclofenac suppository group, RL group, and a combination group. RESULTS: Eight of 57 patients (14.03%) in the diclofenac group, 9 of 57 patients (15.78%) in the RL group, and 6 of 57 patients (10.52%) in the combination group developed PEP. The incidence of PEP between the three groups was not statistically significant (P = 0.70). Serum amylase level of >252 U/L had 91.3% sensitivity and 92.6% specificity for the diagnosis of PEP. CONCLUSIONS: Post-ERCP pancreatitis is usually mild to moderate 95% times. Female sex, age younger than 50 years, a benign indication of ERCP, and low bilirubin levels have higher chances of PEP. A combination of rectal diclofenac and hydration with RL does not offer better protection for PEP, as compared with individual prophylaxis.