Advanced and salvage techniques for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography: a randomized trial of outcomes and efficacy.

BACKGROUND AND AIMS: Difficult biliary cannulation (DBC) complicates 5% to 20% of ERCP procedures. Advanced techniques, double-guidewire technique (DGT), transpancreatic sphincterotomy (TPS), and precut fistulotomy, have been introduced to improve outcomes, but their comparative effectiveness remains uncertain. This study compared their efficacy, safety, and time-related performance using robust statistical analyses.

METHODS

This randomized trial was conducted from March 2019 to March 2022 at 2 tertiary centers in Egypt. A total of 150 patients with DBC were assigned to DGT, TPS, or precut fistulotomy (n = 50 each). Patients included those with difficult biliary cannulation secondary to both malignant and benign biliary obstruction. Primary outcomes included initial and final cannulation success (final success defined as success with the same initially assigned salvage technique on a second attempt). Secondary endpoints were procedure time, contrast dye usage, adverse events, and hospital stay. Kaplan-Meier and cumulative incidence analyses assessed time-dependent success. Multivariate logistic regression identified predictors of outcomes.

RESULTS

Initial success rates were 72% (DGT), 68% (TPS), and 68% (precut) (P = .882). Final success reached 100% in all groups. Median cannulation times were 21 minutes (DGT), 17.5 minutes (TPS), and 18 minutes (precut) (P = .145). Precut required less contrast dye (P < .005). Post-ERCP pancreatitis occurred in 10% (DGT), 22% (TPS), and 24% (precut) (P = .151). Other adverse events and outcomes showed no significant differences.

CONCLUSIONS

DGT, TPS, and precut fistulotomy achieved comparable efficacy and safety in patients with DBC. The selection of salvage technique should be individualized and based on patient anatomy, operator expertise, and local resources.

GOV IDENTIFIER: XNCT06315647; https://clinicaltrials.gov/study/NCT06315647.