Endoscopic Ultrasound-Guided Rendezvous Technique Versus Precut Sphincterotomy as Salvage Technique in Patients With Benign Biliary Disease and Difficult Biliary Cannulation : A Randomized Controlled Trial.

BACKGROUND

The 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.

OBJECTIVE

To compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction.

DESIGN

Participant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613).

SETTING

Tertiary care academic institute from July 2020 to May 2021.

PARTICIPANTS

All patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy.

INTERVENTION

Patients 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.

MEASUREMENTS

The primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events.

RESULTS

In total, 100 patients were randomly assigned to EUS-RV ( = 50) and precut sphincterotomy ( = 50). The technical success rate (92% vs. 90%; = 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.

LIMITATION

Single center study done by experts.

CONCLUSION

Endoscopic 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 SOURCE

None.