Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

Thomas Jefferson University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Biliary Obstruction Due to Common Bile Duct Stone; Malignant Bile Duct Obstruction

Treatments: Procedure: Needle Knife Fistulotomy; Procedure: standard biliary cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06694038

18D.632

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: older than 18 years of age -

Exclusion Criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

186 participants in 2 patient groups

Standard Cannulation

Active Comparator group

Description:

Standard Biliary Cannulation

Treatment:

Procedure: standard biliary cannulation

NKF Cannulation

Experimental group

Description:

Biliary Cannulation using NKF technique

Treatment:

Procedure: Needle Knife Fistulotomy