Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation

March 7, 2024 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ERCP with intented bile duct cannulation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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