POCS in Liver Transplantation Patients

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Device: Spy Glass DS

• Registration Number: NCT03205072
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2018-01-25
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP & Spy Glass DS	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.

Primary Outcome Measures

Name	Time	Method
Impact of Per-Oral Cholangioscopy on Patient Management	12 Months	To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.

Secondary Outcome Measures

Name	Time	Method
Technical Success	12 Months	Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.
Serious Adverse Events	12 Months	Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations.
Number of biliary re-interventions	12 Months	Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy.
Patient Management	3 and 12 Months	Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.
Evaluation	12 Months	Evaluation by surgeon of whether or not POCS impacted patient management post procedure.
Relationship between endoscopic findings on POCS visualization	12 Months	Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.

Trial Locations

Locations (5)

New York Presbyterian Hospital CUMC; 🇺🇸 New York, New York, United States

Hospital das Clinicas; 🇧🇷 São Paulo, Brazil

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain