Needle-Knife Fistulotomy Versus Needle-Knife Papillotomy in Difficult Biliary Cannulation: A Systematic Review and Meta-Analysis.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is an essential endoscopic therapeutic modality for biliary and pancreatic diseases. Needle-knife fistulotomy (NKF) and papillotomy (NKP) are the two most commonly used rescue techniques for patients with difficult biliary cannulation. However, there remains a need for comparative studies on these approaches to inform clinical decision-making. This meta-analysis aimed to evaluate the efficacy and safety of NKF compared to NKP as a rescue technique in difficult biliary cannulation after failed conventional ERCP.

Methods: We searched PubMed, Scopus, Embase, and Web of Science databases through November 2023 to include all studies that directly compared the outcomes of NKF with NKP in difficult biliary cannulation. Single-arm studies were excluded. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous data related to clinical events were calculated using the Mantel-Haenszel method within a random-effect model. The primary outcome was the biliary cannulation success rate.

Results: Four studies with 823 patients (n = 376 NKF vs. n = 447 NKP) were included in our analysis. There was no significant difference between the two groups in biliary cannulation success rate (91.7% vs. 86.9%, respectively; OR = 1.54, 95% CI: 0.21 - 2.49, P = 0.14; I² = 0%). However, the overall rate of adverse events was significantly lower in the NKF group than in the NKP group (OR = 0.46, 95% CI: 0.25 - 0.84, P = 0.01). Pancreatitis (OR = 0.23, 95% CI: 0.05 - 1.11, P = 0.07) and bleeding (OR = 1.43, 95% CI: 0.59 - 3.46, P = 0.42) were similar between the two groups. No significant differences in cholangitis, cholecystitis, perforation, or mortality were observed.

Conclusions: Our meta-analysis indicates comparable success rates in comparing NKF and NKP techniques for difficult biliary cannulation after failed conventional ERCP cannulation. Notably, the NKF technique significantly reduces overall adverse events compared to NKP, suggesting that NKF may be preferable due to its favorable safety profile. Additional randomized controlled trials (RCTs) are warranted to evaluate the interval benefit of an NKF technique.