S2163 Comparing Needle-Knife Fistulotomy to Transpapillary Cannulation for Choledocholithiasis: A Meta-Analysis of Stone Clearance and Complication Rates

Introduction: Choledocholithiasis affects 10%–20% of gallstone patients and is a leading cause of biliary obstruction worldwide. Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for bile duct stone removal, with success rates over 85%–95%. Needle-knife fistulotomy (NKF), originally a rescue technique for difficult cannulation, is now increasingly considered as a primary approach due to promising safety and efficacy data. However, its comparative effectiveness versus standard cannulation for stone clearance remains unclear. This meta-analysis evaluates current evidence to determine if NKF offers equivalent success and complication rates in managing choledocholithiasis. Methods: Following PRISMA, we searched Medline, PubMed, EMBASE, Cochrane Library, Google Scholar, and ClinicalTrials.gov for English randomized controlled trials (RCTs) and cohorts up to April 2025 comparing needle-knife fistulotomy (NKF) vs standard cannulation (SC) in ERCP for choledocholithiasis. Primary outcome was stone removal; secondary included cannulation success and complications. Six studies (2 RCTs, 4 cohorts) were analyzed using RevMan with effect models based on heterogeneity. Results: A total of 1,333 patients from 6 studies (662 NKF, 671 SC) were analyzed. Stone clearance (RR 0.97, 95% CI: 0.94–1.00) and cannulation success (RR 1.09, 95% CI: 0.95–1.25) were comparable between groups, showing NKF is non-inferior to standard cannulation. Mean stone size showed no significant difference (mean difference 0.60 mm, 95% CI: –0.08 to 1.27). NKF patients had a higher, but non-significant, rate of repeat ERCP (RR 1.39, 95% CI: 0.89–2.16). Adverse events including pancreatitis, bleeding, perforation, and cholangitis, were similar. Biliary stent use was also comparable. Overall, NKF is non-inferior to standard cannulation in efficacy and safety. Conclusion: This meta-analysis demonstrates non inferiority of needle-knife fistulotomy (NKF) over standard transpapillary cannulation for stone clearance in choledocholithiasis. Although stone size may play a role in procedural success, this was not statistically significant in our analysis. Factors such as papillary morphology and procedural complexity could also influence outcomes. With growing evidence supporting NKF’s safety and efficacy, treatment decisions should be guided by careful pre-procedural assessment and risk stratification. Further studies are needed to clarify these factors and optimize patient selection for NKF.