POCS in Liver Transplantation Patients

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.

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.