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Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

NCT04559867 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2024-04-03

No results posted yet for this study

Summary

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts.

Patients will consent to allow the study physician to access these areas of the digestive system by either making a cut called a needle-knife fistulotomy or a sphincterotomy.

Conditions

  • Cholangiopancreatography, Endoscopic Retrograde
  • Biliary Tract Diseases

Interventions

PROCEDURE

Needle knife fistulotomy

A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP.

PROCEDURE

Sphincterotomy

A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.

Sponsors & Collaborators

  • Lawrence Charles Hookey

    lead OTHER

Principal Investigators

  • Robert Bechara, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2024-03-30
Completion
2024-12-10

Countries

  • Canada

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 NCT04559867 on ClinicalTrials.gov