NCT06694038

CompletedPhase 1/2

Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

Thomas Jefferson University Source

Thomas Jefferson University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

18D.632

Study Type

interventional

Actual enrollment (reported)

186

Locations

1 country

Sites

1

Timeline

Study Start

January 31, 2019

Actual (reported)

Primary Completion

June 25, 2021

Actual (reported)

Study Completion

July 1, 2021

Actual (reported)

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 SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 186 participants
Study completion date: July 1, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 31, 2019
Actual (reported)
Primary Completion
June 25, 2021
Actual (reported)
Study Completion
July 1, 2021
Actual (reported)
First Submitted
November 15, 2024
Actual (reported)
First Posted
November 19, 2024
Actual (reported)

Last Updated: November 19, 2024
Status Verified: November 2024
Last Update Submitted: November 15, 2024

Conditions

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

Keywords

jaundicebile duct obstructionabnormal liver enzymes

Outcome Measures

Primary Outcomes (1)

post ERCP pancreatitis
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
within 48 hours of the procedure

Secondary Outcomes (2)

Bleeding
within 48 hours
Perforation
within 48 hours

Study Arms (2)

Standard Cannulation

ACTIVE COMPARATOR

Standard Biliary Cannulation

Procedure: standard biliary cannulation

NKF Cannulation

EXPERIMENTAL

Biliary Cannulation using NKF technique

Procedure: Needle Knife Fistulotomy

Interventions

Needle Knife FistulotomyProcedure

Biliary access using needle knife fistulotomy technique

NKF Cannulation

standard biliary cannulationProcedure

standard biliary cannulation

Standard Cannulation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Thomas Jefferson University
Otherlead

Study Sites (1)

Thomas Jefferson University Hospial

Philadelphia, Pennsylvania, 19107, United States

MeSH Terms

Conditions

JaundiceCholestasis

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Enrollment

186 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 19, 2024

Study Start

January 31, 2019

Actual (reported)

Primary Completion

June 25, 2021

Actual (reported)

Study Completion

July 1, 2021

Actual (reported)

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06694038
Data provider: ClinicalTrials.gov
Source updated: 2024-11-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:59 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Standard Cannulation

NKF Cannulation

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations