Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Documentation of biliary ductal changes in post-liver transplant biliary complications.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SpyGlass (direct visualization system) choledochoscopy (Procedure)
Outcomes
Primary Outcomes
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
- Number of Participants with Adverse Events.(2 years)
Investigators
FERNANDA PRATA MARTINS
Attending physician
Hospital Israelita Albert Einstein