Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation
Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography
1 other identifier
observational
20
0 countries
N/A
Brief Summary
To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedMarch 15, 2024
March 1, 2024
9 months
March 7, 2024
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of treatment success
Rate of successful cannulation of the bile duct after PreCut-papillectomy
During endoscopy
Adverse event rate
Rate of adverse events, as classifed by ASGE classification
Up to 30 days
Interventions
Papillectomy prior to bile duct cannulation during ERCP
Eligibility Criteria
Patients undergoing ERCP with intented bile duct cannulation
You may qualify if:
- Difficult cannulation of bile duct
You may not qualify if:
- post-surgical upper GI anatomy
- previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
- papilla within a diverticulum
- coagulation disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2024
First Posted
March 15, 2024
Study Start
April 1, 2024
Primary Completion
December 31, 2024
Study Completion
February 28, 2025
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share