Per-Oral Cholangioscopy (POCS) in Liver Transplantation Patients

Completed

Conditions: post-liver transplant BD strictures
A clinical suspicion of post-liver transplant bile duct stricture(s). Biliary complications in post-liver transplant
10019654

Registration Number: NL-OMON55336

Lead Sponsor: Boston Scientific Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Liver transplantation at least 1 month prior to POCS procedure
2. Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
3. Prior cross-sectional imaging (MRI and/or US and/or CT)
4. Suspected anastomotic biliary stricture(s)
5. Diameter of bile ducts deemed sufficient to accommodate cholangioscopy
system based on baseline imaging.
6. Willing and able to provide a written informed consent to participate in the
study
7. Willing and able to comply with study procedures and follow-up schedule

Exclusion Criteria

1. Contraindication for an ERCP per local standard of practice
2. Contraindication for POCS per local standard of practice
3. Prior treatment of biliary anastomotic stricture
4. < 18 years old
5. Documented life expectancy of less than 12 months
6. Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is to evaluate the impact of the addition of<br /><br>POCS to same setting ERCP on the recommended management of post-liver<br /><br>transplantation biliary complications.<br /><br><br /><br>• Recommended management options based on ERCP alone will be recorded<br /><br>immediately following the ERCP and before starting the POCS portion<br /><br>of the procedure; recommended management options based on ERCP and POCS<br /><br>combined will be recorded immediately following the POCS<br /><br>procedure.<br /><br>• Success is defined as different recommended management options based on ERCP<br /><br>alone versus on ERCP and POCS combined.</p><br>

Secondary Outcome Measures