NCT06694038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

November 15, 2024

Last Update Submit

November 15, 2024

Conditions

Biliary Obstruction Due to Common Bile Duct StoneMalignant 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospial

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

JaundiceCholestasis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
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

Primary Completion

June 25, 2021

Study Completion

July 1, 2021

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Patients were not asked to consent for the data to be shared with other institutions

Locations

US(1)