Clinical trial NCT03205072: POCS in Liver Transplantation Patients
Official title: Per-Oral Cholangioscopy in Liver Transplantation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Keywords: ERCP
Per-Oral Cholangioscopy
Liver Transplantation
Spy Glass
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of Per-Oral Cholangioscopy on Patient Management
timeFrame: 12 Months
Secondary outcomes:
measure: Technical Success
timeFrame: 12 Months
measure: Serious Adverse Events
timeFrame: 12 Months
measure: Number of biliary re-interventions
timeFrame: 12 Months
measure: Patient Management
timeFrame: 3 and 12 Months
measure: Relationship between endoscopic findings on POCS visualization
timeFrame: 12 Months
measure: Evaluation
timeFrame: 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital CUMC
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: São Paulo
country: Brazil
facility: Hospital das Clinicas
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Columbia University
name: Amrita Sethi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clinicas University of Sao Paulo
name: Eduardo De Moura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Adam Slivka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Andres Cardenas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Marco Bruno, MD
role: PRINCIPAL_INVESTIGATOR
References: