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Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

NCT06694038 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-11-19

No results posted yet for this study

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

PROCEDURE

Needle Knife Fistulotomy

Biliary access using needle knife fistulotomy technique

PROCEDURE

standard biliary cannulation

standard biliary cannulation

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2021-06-25
Completion
2021-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694038 on ClinicalTrials.gov