• Arup Choudhury, Jayanta Samanta, Gaurav Muktesh, Jahnvi Dhar, Antriksh Kumar, Jimil Shah, Marco Spadaccini, Pankaj Gupta, Alessandro Fugazza, Vikas Gupta, Thakur Deen Yadav, Rakesh Kochhar, Cesare Hassan, Alessandro Repici, and Antonio Facciorusso.
• Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India (A.C., J.Samanta, G.M., J.D., A.K., J.Shah, R.K.).
• Ann. Intern. Med. 2024 Oct 1; 177 (10): 136113691361-1369.

BackgroundThe standard salvage technique used for difficult bile duct cannulation is precut sphincterotomy, whereas endoscopic ultrasound-guided rendezvous technique (EUS-RV) is a relatively newer method. Prospective comparative data between these 2 techniques as salvage for biliary access in patients with benign biliary disease and difficult bile duct cannulation is lacking.ObjectiveTo compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction.DesignParticipant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613).SettingTertiary care academic institute from July 2020 to May 2021.ParticipantsAll patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy.InterventionPatients were randomly assigned by computer-generated randomized blocks sequence in 1:1 fashion to either EUS-RV or precut sphincterotomy. Patients with failure in EUS-RV were crossed over to precut sphincterotomy and vice versa.MeasurementsThe primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events.ResultsIn total, 100 patients were randomly assigned to EUS-RV (n = 50) and precut sphincterotomy (n = 50). The technical success rate (92% vs. 90%; P = 1.00; relative risk, 1.02 [95% CI, 0.90 to 1.16]), median procedure time (10.1 vs. 9.75 minutes), and overall complication rate (12% vs. 10%; relative risk, 1.20 [CI, 0.39 to 3.68]) were similar between the 2 groups. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. All failed cases in either salvage group could be successfully cannulated when crossed over to the other group.LimitationSingle center study done by experts.ConclusionEndoscopic ultrasound-guided rendezvous technique and precut sphincterotomy have similar success rates as salvage techniques in the technically challenging cohort of difficult bile duct cannulation for benign biliary disease, with acceptable complications rates.Primary Funding SourceNone.

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