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NCT06310460 Clinical Trial

Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:
Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06310460
Other study ID # PCP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date February 28, 2025

Study information
Verified date March 2024
Source Kliniken Ludwigsburg-Bietigheim gGmbH
Contact Andreas Wannhoff, Dr.
Phone +49-7141-67204
Email Andreas.Wannhoff@rkh-gesundheit.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date February 28, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Cholangiopancreatography, Endoscopic Retrograde

Intervention

Procedure:
• Papillectomy
Papillectomy prior to bile duct cannulation during ERCP

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of treatment success Rate of successful cannulation of the bile duct after PreCut-papillectomy During endoscopy
Primary Adverse event rate Rate of adverse events, as classifed by ASGE classification Up to 30 days
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