Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

Phase 1

Completed

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

• Registration Number: NCT06694038
• Lead Sponsor: Thomas Jefferson University

Brief 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...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-31
• Primary Completion: 2021-06-25
• Study Completion: 2021-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

older than 18 years of age -

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
post ERCP pancreatitis	within 48 hours of the procedure	Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure

Secondary Outcome Measures

Name	Time	Method
Perforation	within 48 hours	Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure.
Bleeding	within 48 hours	Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis

Trial Locations

Locations (1)

Thomas Jefferson University Hospial; 🇺🇸 Philadelphia, Pennsylvania, United States