POCS in Liver Transplantation Patients

Completed

Conditions studied: Liver Transplant; Complications

In brief

A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.

Key facts

Study ID

NCT03205072

Run by

Boston Scientific Corporation

People needed

42

Starts

2018-01-25

Expected to finish

2022-03-24

Last updated by the study team

2022-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Contraindication for an ERCP per local standard of practice
• Deemed contraindicated for POCS per local standard of practice
• Prior biliary treatment of biliary anastomotic stricture
• < 18 years old
• Documented life expectancy of less than 12 months.

Where it is running

• New York Presbyterian Hospital CUMC — New York, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Hospital das Clinicas — São Paulo, Brazil
• Erasmus Medical Center — Rotterdam, Netherlands
• Hospital Clinic de Barcelona — Barcelona, Spain

Full record on ClinicalTrials.gov

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