Effectiveness and Safety of Single-Operator Cholangioscopy in the Management of Difficult Biliary Stones: A Systematic Review and Meta-Analysis

Abstract

Difficult bile duct stones remain one of the most challenging indications for therapeutic endoscopic retrograde cholangiopancreatography (ERCP), particularly when conventional extraction techniques fail. Single-operator cholangioscopy (SOC) has emerged as an alternative approach; however, evidence regarding its comparative efficacy and safety remains limited. This study aimed to evaluate and synthesize the available evidence on the use of SOC for the management of difficult bile duct stones.

We conducted a systematic review in accordance with Cochrane methodology and assessed the certainty of evidence using the Grade of Recommendation Assessment, Development, and Evaluation ( approach. Medline and Embase were searched from 2014 to 2025 for primary studies comparing SOC with ERCP plus large-balloon papillary dilation. Outcomes of interest included successful stone extraction, procedure time, and the incidence of procedure-related adverse events. A random-effects meta-analysis was performed.

Three randomized controlled trials (n = 224) were included. Compared with ERCP plus balloon dilation, no statistically significant difference in successful stone clearance was observed with SOC (relative risk [RR] 1.25; 95% confidence interval [CI] 0.95–1.63), although the point estimate numerically favored SOC. Likewise, no statistically significant differences were observed in procedure time (standardized mean difference 0.46; 95% CI −0.21 to 1.13) or procedure-related adverse events (RR 0.88; 95% CI 0.11–7.13); however, estimates for adverse events were imprecise because of the limited number of events. The certainty of evidence was rated as moderate for successful stone clearance and procedure time, and low for adverse events.

SOC may show a potential trend toward improved stone clearance. However, the available randomized evidence remains limited by the small number of studies, small sample size, high risk of bias, and substantial imprecision, particularly for infrequent adverse events. Therefore, no definitive conclusions regarding comparative efficacy or safety can be drawn, and adequately powered randomized controlled trials are warranted.