SpyGlass in Post Liver Transplant Biliary Complications.
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|ClinicalTrials.gov Identifier: NCT02543151|
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplant Disorder Biliary Anastomosis Complication||Procedure: SpyGlass (direct visualization system) choledochoscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||October 2018|
Experimental: SpyGlass Choledochoscopy procedure
Any patient referred to endoscopic management for biliary post liver transplant complication without previous treatment will be submitted to SpyGlass (direct visualization system) choledochoscopy procedure.
Procedure: SpyGlass (direct visualization system) choledochoscopy
SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment
- 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
- Number of Participants with Adverse Events. [ Time Frame: 2 years ]Secondary outcomes include the description of adverse events
- Procedural success rate: [ Time Frame: 1 year ]defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543151
|Hospital Israelita Albert Einstein|
|Sao Paulo, SP, Brazil|
|Study Director:||ANGELO P FERRARI, MD||Attending physician|
|Principal Investigator:||FERNANDA P MARTINS, MD||Attending physician|