NCT02543151

SpyGlass in Post Liver Transplant Biliary Complications.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Transplant Disorder
• Biliary Anastomosis Complication

Interventions

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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-06-01
• Completion: 2018-10-01
• First posted: 2015-09-07
• Last updated: 2019-04-17

Locations

1 site across 1 country: Brazil