Biliary stenting with and without endoscopic sphincterotomy in patients with malignant biliary obstruction: meta-analysis of randomized controlled trials.

Endoscopic biliary sphincterotomy (EBS) is commonly performed during endoscopic retrograde cholangiopancreatography (ERCP) in patients with malignant biliary obstruction (MBO) before stent placement. Studies comparing adverse events between patients with MBO undergoing ERCP with and without EBS have reported conflicting results. We conducted an updated meta-analysis including randomized controlled trials (RCTs) only to evaluate the safety of EBS in these patients and its efficacy in decreasing the risk of post-ERCP pancreatitis (PEP). We reviewed several databases from inception to 10 January 2024 to identify RCTs that compared adverse events of biliary stenting with and without EBS in the patients with MBO. Our outcomes of interest were PEP, successful stent insertion, and adverse events such as cholangitis, bleeding, perforation, stent migration, and stent occlusion. We calculated pooled risk ratio with 95% confidence intervals (CIs) for all of the outcomes and used a random effect model to analyze the data. We included six RCTs with 1070 patients. There was no significant difference in rate of PEP between groups [risk ratio (95% CI): 0.50 (0.23-1.08)]. We found no significant difference in the rate of successful stent insertion between groups [risk ratio (95% CI): 1.01 (0.99-1.02)]. The rate of post-ERCP bleeding was significantly higher in EBS group [risk ratio (95% CI): 7.43 (2.45-22.53)]. We found no significant difference in rates of cholangitis, perforation, stent migration, and stent occlusion between groups. EBS does not decrease the risk of PEP in patients with MBO and is associated with increased risk of bleeding.