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SpyGlass in Post Liver Transplant Biliary Complications.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02543151
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
FERNANDA PRATA MARTINS, Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment Phase
Liver Transplant Disorder Biliary Anastomosis Complication Procedure: SpyGlass (direct visualization system) choledochoscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: SpyGlass (direct visualization system) choledochoscopy
SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants with Adverse Events. [ Time Frame: 2 years ]
    Secondary outcomes include the description of adverse events


Other Outcome Measures:
  1. Procedural success rate: [ Time Frame: 1 year ]
    defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543151


Locations
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Brazil
Hospital Israelita Albert Einstein
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Study Director: ANGELO P FERRARI, MD Attending physician
Principal Investigator: FERNANDA P MARTINS, MD Attending physician

Publications:
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Responsible Party: FERNANDA PRATA MARTINS, Attending physician, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02543151     History of Changes
Other Study ID Numbers: 1439-11
28005314.5.0000.0071 ( Other Identifier: CONEP )
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by FERNANDA PRATA MARTINS, Hospital Israelita Albert Einstein:
Biliary stricture
Cholangioscopy
Spyglass
Liver transplant