POCS in Liver Transplantation Patients

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03205072
• Collaborator: (none)
• Enrollment: 42
• Locations: 5
• Actual Duration (Months): 49.9
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 42 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Per-Oral Cholangioscopy in Liver Transplantation Patients
• Actual Study Start Date: Jan 25, 2018
• Actual Primary Completion Date: Mar 24, 2022
• Actual Study Completion Date: Mar 24, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Technical Success [12 Months]

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

2. 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.

3. 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.

4. Patient Management [3 and 12 Months]

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

5. 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.

6. Evaluation [12 Months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital CUMC	New York	New York	United States	10032
2	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
3	Hospital das Clinicas	São Paulo		Brazil	05403
4	Erasmus Medical Center	Rotterdam		Netherlands	3015
5	Hospital Clinic de Barcelona	Barcelona		Spain	08036

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03205072
• Other Study ID Numbers: E7114
• First Posted: Jul 2, 2017
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Boston Scientific Corporation: ERCP; Per-Oral Cholangioscopy; Liver Transplantation; Spy Glass

Study Results

No Results Posted as of Jul 28, 2022