POCS in Liver Transplantation Patients

Boston Scientific

Status: Completed

Conditions: Liver Transplant; Complications

Treatments: Device: Spy Glass DS

Study type: Observational

Funder types: Industry

Identifiers

NCT03205072

E7114

Details and patient eligibility

About

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.

Full description

The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Suspicion of 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. Deemed contraindicated for POCS per local standard of practice
3. Prior biliary treatment of biliary anastomotic stricture
4. < 18 years old
5. Documented life expectancy of less than 12 months.

Trial design

42 participants in 1 patient group

ERCP & Spy Glass DS

Description:

Patients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures.

Treatment:

Device: Spy Glass DS