Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

NCT ID: NCT06694038

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Cannulation

Standard Biliary Cannulation

Group Type ACTIVE_COMPARATOR

standard biliary cannulation

Intervention Type PROCEDURE

standard biliary cannulation

NKF Cannulation

Biliary Cannulation using NKF technique

Group Type EXPERIMENTAL

Needle Knife Fistulotomy

Intervention Type PROCEDURE

Biliary access using needle knife fistulotomy technique

Interventions

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Needle Knife Fistulotomy

Biliary access using needle knife fistulotomy technique

Intervention Type PROCEDURE

standard biliary cannulation

standard biliary cannulation

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University Hospial

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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18D.632

Identifier Type: -

Identifier Source: org_study_id

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