POCS in Liver Transplantation Patients

N/ACompletedNCT03205072

Boston Scientific Corporation42 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Transplant; Complications

Interventions

Spy Glass DSDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

Impact of Per-Oral Cholangioscopy on Patient Management

To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.

Time frame: 12 Months

Secondary Outcomes

Technical Success

Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.

Time frame: 12 Months

Serious Adverse Events

Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations.

Time frame: 12 Months

Number of biliary re-interventions

Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy.

Time frame: 12 Months

Patient Management

Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.

Time frame: 3 and 12 Months

Relationship between endoscopic findings on POCS visualization

Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.

Time frame: 12 Months

Evaluation

Evaluation by surgeon of whether or not POCS impacted patient management post procedure.

Data from ClinicalTrials.gov

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