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Completed

NCT Number: NCT06694038

Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

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.

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Key information

Conditions

Biliary Obstruction Due to Common Bile Duct Stone Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Hyperbilirubinemia Jaundice Malignant Bile Duct Obstruction Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Thomas Jefferson University Hospial

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Needle Knife Fistulotomy

Procedure

Biliary access using needle knife fistulotomy technique

standard biliary cannulation

Procedure

standard biliary cannulation

Primary outcomes

  1. post ERCP pancreatitis

    Time frame: 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 outcomes

  1. Bleeding

    Time frame: within 48 hours

    Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis

  2. Perforation

    Time frame: within 48 hours

    Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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