Endoscopic Sphincterotomy Plus Large Balloon Dilation Versus Endoscopic Sphincterotomy Alone for Patients with Common...

Endoscopic sphincterotomy (ES) and endoscopic papillary balloon dilation (EPBD) are established treatments for common bile duct (CBD) stones, each with limitations. Endoscopic sphincterotomy with large-balloon dilation (ESBD) combines both techniques, but its efficacy versus ES alone remains controversial. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing ESBD with ES alone for the management of CBD stones.

We searched PubMed, Scopus, Embase, Ovid, Web of Science, and Cochrane Library for RCTs comparing ESBD versus ES alone in adults with CBD stones. Primary outcomes were total and first-session stone clearance and mechanical lithotripsy (ML) use. Secondary outcomes included procedure time and complications. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using fixed or random effect models based on heterogeneity. Subgroup analysis was performed based on stone size and balloon dilation time. Risk of bias was assessed using the Cochrane ROB-2 tool, and the certainty of evidence was evaluated using the GRADE approach.

Seventeen RCTs with 2671 patients were included. ESBD significantly improved first-session stone clearance (RR 1.11; 95% CI: 1.04 to 1.17; P = 0.001), reduced ML use (RR 0.47; 95% CI: 0.34-0.65; P < 0.0001), and shortened procedure time (MD - 3.44 min; 95% CI: - 5.71 to - 1.17; P = 0.003) compared with ES alone. Total stone clearance was similar between groups. ESBD significantly reduced postoperative hemorrhage (RR 0.55; 95% CI 0.34 to 0.90; P = 0.02) and stone recurrence (RR 0.53; 95% CI 0.32 to 0.87; P = 0.01), with no difference in pancreatitis or other complications. ESBD significantly increases first-session stone removal and decreases ML use in both small- and large-stone-sized groups.

Current low- to very-low-certainty evidence suggests possible procedural advantages of ESBD over ES alone, including higher first-session stone clearance, reduced mechanical lithotripsy use, shorter procedure time, and lower rates of bleeding and stone recurrence, across both large and small CBD stones. These findings are hypothesis-generating and should not be considered practice-changing until confirmed by high-quality randomized controlled trials (RCTs).