Comparative Efficacy and Safety of Needle-Knife Fistulotomy vs Standard Cannulation: A Practical Randomized Controlled Trial

BACKGROUND AND AIMS

Current literature suggests that needle-knife fistulotomy (NKF) technique should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared with those of standard cannulation (SC) for primary biliary access performed by advanced endoscopists with a range of experience, including advanced endoscopy trainees.

METHODS

In total, 186 patients were randomly assigned to either NKF or SC as means of primary biliary access and 137 patients were included in the final analysis (clinicaltrials.gov; NCT06694038). The primary outcome was incidence of post–endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Secondary outcomes were biliary access success, time to biliary access, incidence of bleeding, and incidence of perforation.

RESULTS

Of the 137 procedures included in the study, 99 (72.3%) were carried out by advanced endoscopy trainees under supervision, 26 (19.0%) by advanced endoscopists without significant previous NKF experience, and 12 (8.8%) by an experienced advanced endoscopist with expertise in NKF. In the group that was randomized to SC, 6 (8.22%) patients developed pancreatitis vs 5 (7.81%) patients randomized to NKF arm (P = 0.93). Average time to biliary access within 20 minutes was significantly shorter with SC at 268 seconds (95% CI, 198-338 seconds) vs 380 seconds (95% CI, 292-466 seconds; P < 0.05) in the NKF arm.

CONCLUSION

NKF is a safe and effective technique for primary biliary access during ERCP performed by advanced endoscopists with a wide range of experience, with post-ERCP pancreatitis equivalent to SC. NKF, in this study, took slightly longer than SC to achieve bile duct access. Use of either or both techniques resulted in a 100% successful bile duct cannulation in patients with favorable anatomy.