SpyGlass in Post Liver Transplant Biliary Complications.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02543151

Enrollment

Registered

2015-09-07

Start date

2016-03-31

Completion date

2018-10-31

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Anastomosis Complication, Liver Transplant Disorder

Keywords

Biliary stricture, Cholangioscopy, Spyglass, Liver transplant

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.

Interventions

PROCEDURESpyGlass (direct visualization system) choledochoscopy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events.	2 years	Secondary outcomes include the description of adverse events

Other

Measure	Time frame	Description
Procedural success rate:	1 year	defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026