NCT03205072

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

4.2 years

First QC Date

June 26, 2017

Last Update Submit

July 26, 2022

Conditions

Liver Transplant; Complications

Keywords

ERCPPer-Oral CholangioscopyLiver TransplantationSpy Glass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Technical Success

    12 Months

  • Serious Adverse Events

    12 Months

  • Number of biliary re-interventions

    12 Months

  • Patient Management

    3 and 12 Months

  • Relationship between endoscopic findings on POCS visualization

    12 Months

  • +1 more secondary outcomes

Study Arms (1)

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

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.

ERCP & Spy Glass DS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Liver transplantation at least 1 month prior to POCS procedure
  • Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
  • Prior cross sectional imaging (MRI and/or US and/or CT)
  • Suspicion of anastomotic biliary stricture(s)
  • Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
  • Willing and able to provide a written informed consent to participate in the study
  • Willing and able to comply with study procedures and follow-up schedule

You may not qualify if:

  • Contraindication for an ERCP per local standard of practice
  • Deemed contraindicated for POCS per local standard of practice
  • Prior biliary treatment of biliary anastomotic stricture
  • \< 18 years old
  • Documented life expectancy of less than 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

New York Presbyterian Hospital CUMC

New York, New York, 10032, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Hospital das Clinicas

São Paulo, 05403, Brazil

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies if needed at the discretion of the PI.

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

January 25, 2018

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)BR(1)NL(1)ES(1)