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Completed

NCT Number: NCT03205072

POCS 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.

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Key information

Conditions

Liver Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clinicas, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Spy Glass DS

Device

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.

Primary outcomes

  1. Impact of Per-Oral Cholangioscopy on Patient Management

    Time frame: 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 outcomes

  1. Technical Success

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 Months

    Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.

  6. Evaluation

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Per-Oral Cholangioscopy in Liver Transplantation Patients

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2017
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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