OBJECTIVE:Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly used procedure. Pancreatitis is its most common complication. As the injury may be mediated by oxidative stress, it could be ameliorated by antioxidants. METHODS: We conducted a double-blind trial, giving the patients a single dose of natural beta-carotene or placebo, 12 hours prior to procedure, and monitoring them for 24 hours post-procedure for procedure complications, antioxidant levels, and plasma oxidation. RESULTS: The overall incidence of acute pancreatitis according to our definition was 9.6%. The incidence of pancreatitis was not significantly different between the beta-carotene group (10%) and the placebo group (9.4%). Four patients in the placebo group had severe pancreatitis (2.22%), but none in the beta-carotene group. This difference is statistically significant. CONCLUSION: We did not see a reduction in the incidence of post-ERCP pancreatitis, but there may be some protective effect of treatment with beta-carotene regarding the severity of disease.
RCT Entities:
OBJECTIVE: Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly used procedure. Pancreatitis is its most common complication. As the injury may be mediated by oxidative stress, it could be ameliorated by antioxidants. METHODS: We conducted a double-blind trial, giving the patients a single dose of natural beta-carotene or placebo, 12 hours prior to procedure, and monitoring them for 24 hours post-procedure for procedure complications, antioxidant levels, and plasma oxidation. RESULTS: The overall incidence of acute pancreatitis according to our definition was 9.6%. The incidence of pancreatitis was not significantly different between the beta-carotene group (10%) and the placebo group (9.4%). Four patients in the placebo group had severe pancreatitis (2.22%), but none in the beta-carotene group. This difference is statistically significant. CONCLUSION: We did not see a reduction in the incidence of post-ERCP pancreatitis, but there may be some protective effect of treatment with beta-carotene regarding the severity of disease.