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OpenTrials
Completed

NCT Number: NCT02543151

SpyGlass in Post Liver Transplant Biliary Complications.

The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.

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Key information

Conditions

Liver Transplant Disorder Biliary Anastomosis Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, Brazil

About this study

A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.

Consecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.

In those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.

After final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment

Exclusion criteria

  • Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
  • Below 18 years of age
  • Pregnancy

Treatment and study plan

SpyGlass (direct visualization system) choledochoscopy

Procedure

SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment

Primary outcomes

  1. Documentation of biliary ductal changes in post-liver transplant biliary complications.

    Time frame: 2 years

    The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications

Secondary outcomes

  1. Number of Participants with Adverse Events.

    Time frame: 2 years

    Secondary outcomes include the description of adverse events

Other outcomes

  1. Procedural success rate:

    Time frame: 1 year

    defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Apr 17, 2019

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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