POCS in Liver Transplantation Patients

Per-Oral Cholangioscopy in Liver Transplantation Patients

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Device: Spy Glass DS

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403
    • Hospital das Clinicas
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus Medical Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital CUMC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cadaveric donor or live donor liver transplantation patients referred for ERCP in the setting of a clinical suspicion of post-liver transplant bile duct stricture(s).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.	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.	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.	12 Months
Patient Management	Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.	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.	12 Months
Evaluation	Evaluation by surgeon of whether or not POCS impacted patient management post procedure.	12 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Amrita Sethi, MD, Columbia University; Principal Investigator: Eduardo De Moura, MD, Hospital das Clinicas University of Sao Paulo; Principal Investigator: Adam Slivka, MD, University of Pittsburgh Medical Center; Principal Investigator: Andres Cardenas, MD, Hospital Clinic of Barcelona; Principal Investigator: Marco Bruno, MD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): March 24, 2022
• Study Completion (ACTUAL): March 24, 2022

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ERCP; Liver Transplantation; Spy Glass; Per-Oral Cholangioscopy
• Other Study ID Numbers: E7114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes