SpyGlass in Post Liver Transplant Biliary Complications.

Hospital Israelita Albert Einstein

Status: Completed

Conditions: Biliary Anastomosis Complication; Liver Transplant Disorder

Treatments: Procedure: SpyGlass (direct visualization system) choledochoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02543151

28005314.5.0000.0071 (Other Identifier)

1439-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SpyGlass Choledochoscopy procedure

Experimental group

Description:

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.

Treatment:

Procedure: SpyGlass (direct visualization system) choledochoscopy