NCT06694038

Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.

Conditions

• Biliary Obstruction Due to Common Bile Duct Stone
• Malignant Bile Duct Obstruction

Interventions

Type	Name	Description
PROCEDURE	Needle Knife Fistulotomy	Biliary access using needle knife fistulotomy technique
PROCEDURE	standard biliary cannulation	standard biliary cannulation

Timeline

• Start date: 2019-01-31
• Primary completion: 2021-06-25
• Completion: 2021-07-01
• First posted: 2024-11-19
• Last updated: 2024-11-19

Locations

1 site across 1 country: United States