Aim: To perform a meta-analysis of large-balloon dilation (LBD) plus endoscopic sphincterotomy (EST) vs EST alone for removal of bile duct stones.
Methods: Databases including PubMed, EMBASE, the Cochrane Library, the Science Citation Index, and important meeting abstracts were searched and evaluated by two reviewers independently. The main outcome measures included: complete stone removal, stone removal in the first session, use of mechanical lithotripsy, procedure time, and procedure-related complications. A fixed-effects model weighted by the Mantel-Haenszel method was used for pooling the odds ratio (OR) when heterogeneity was not significant among the studies. When a Q test or I² statistic indicated substantial heterogeneity, a random-effects model weighted by the DerSimonian-Laird method was used.
Results: Six randomized controlled trials involving 835 patients were analyzed. There was no significant heterogeneity for most results; we analyzed these using a fixed-effects model. Meta-analysis showed EST plus LBD caused fewer overall complications than EST alone (OR = 0.53, 95%CI: 0.33-0.85, P = 0.008); subcategory analysis indicated a significantly lower risk of perforation in the EST plus LBD group (Peto OR = 0.14, 95%CI: 0.20-0.98, P = 0.05). Use of mechanical lithotripsy in the EST plus LBD group decreased significantly (OR = 0.26, 95%CI: 0.08-0.82, P = 0.02), especially in patients with a stone size larger than 15 mm (OR = 0.15, 95%CI: 0.03-0.68, P = 0.01). There were no significant differences between the two groups regarding complete stone removal, stone removal in the first session, post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, infection of biliary tract, and procedure time.
Conclusion: EST plus LBD is an effective approach for the removal of large bile duct stones, causing fewer complications than EST alone.
Keywords: Balloon dilation; Cholangiopancreatography; Choledocholithiasis; Endoscopic retrograde; Endoscopic sphincterotomy; Meta-analysis.