POCS in Liver Transplantation Patients

Liver Transplant; Complications Clinical Trial

Official title:

Per-Oral Cholangioscopy in Liver Transplantation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205072
• Other study ID #: E7114
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: March 24, 2022

Study information

• Verified date: July 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	São Paulo
Netherlands	Erasmus Medical Center	Rotterdam
Spain	Hospital Clinic de Barcelona	Barcelona
United States	New York Presbyterian Hospital CUMC	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Brazil,  Netherlands,  Spain, 

Outcome

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