SpyGlass in Post Liver Transplant Biliary Complications.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Transplant Disorder, Biliary Anastomosis Complication

Intervention / Treatment
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* Procedure: SpyGlass (direct visualization system) choledochoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpyGlass Choledochoscopy procedure<br>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<br>* SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of biliary ductal changes in post-liver transplant biliary complications. | The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events. | Secondary outcomes include the description of adverse events | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary stricture, Cholangioscopy, Spyglass, Liver transplant