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Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Start Date
March 1, 2016
Primary Completion Date
June 1, 2017
Completion Date
October 1, 2018
Last Updated
April 17, 2019
20
ACTUAL participants
SpyGlass (direct visualization system) choledochoscopy
PROCEDURE
Lead Sponsor
Hospital Israelita Albert Einstein
NCT07315204
NCT04186234
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06563570