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Clinical Trials/NCT06310460
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

Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor Class
Other
Responsible Party
Sponsor

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