POCS in Liver Transplantation Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2022-03-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ERCP & Spy Glass DS

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.

Spy Glass DS

Intervention Type DEVICE

The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.

Interventions

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Spy Glass DS

The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No