NCT06310460Not yet recruitingNot Applicable
Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography
Kliniken Ludwigsburg-Bietigheim gGmbH0 sites20 target enrollmentStarted: April 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Rate of treatment success
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Difficult cannulation of bile duct
Exclusion Criteria
- •post-surgical upper GI anatomy
- •previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
- •papilla within a diverticulum
- •coagulation disorder
Outcomes
Primary Outcomes
Rate of treatment success
Time Frame: During endoscopy
Rate of successful cannulation of the bile duct after PreCut-papillectomy
Adverse event rate
Time Frame: Up to 30 days
Rate of adverse events, as classifed by ASGE classification
Secondary Outcomes
No secondary outcomes reported
Investigators
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