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NCT06694038 · ClinicalTrials.gov registry record · Phase 1
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
A Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 186
- Enrollment target
- 1
- Study location
NCT06694038: Completed Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, sponsored by Thomas Jefferson University.
NCT06694038 is a Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction that has completed, run by Thomas Jefferson University. The registered enrollment target is 186 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (210% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06694038, a Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 186 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Needle Knife Fistulotomy
- PROCEDURE standard biliary cannulation
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospial - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 1 |
What the finished NCT06694038 record still lists
NCT06694038 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (210% higher).
The record links to 2 conditions, with Biliary Obstruction Due to Common Bile Duct Stone appearing as the primary indexed condition, and to 2 interventions - of which Needle Knife Fistulotomy is the first listed.
NCT06694038 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06694038 about?
NCT06694038 is a clinical study titled "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 stud...
What is the current status of trial NCT06694038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 186 participants. The study started on 2019-01-31. Estimated completion is 2021-07-01.
What conditions does trial NCT06694038 study?
This clinical trial studies the following conditions: Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction.
What interventions are being tested in trial NCT06694038?
The interventions under investigation include: Needle Knife Fistulotomy (PROCEDURE), standard biliary cannulation (PROCEDURE).
Who is sponsoring clinical trial NCT06694038?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06694038 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06694038's enrollment target sits among peer trials
186 291st of 2000 higher than 1,707 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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