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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

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 7, 2015
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
Documentation of biliary ductal changes in post-liver transplant biliary complications. [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02543151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
Number of Participants with Adverse Events. [ Time Frame: 2 years ]
Secondary outcomes include the description of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
Number of Participants with Adverse Events. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2017)
Procedural success rate: [ Time Frame: 1 year ]
defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.
Original Other Pre-specified Outcome Measures
 (submitted: September 3, 2015)
Procedural success rate: defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved. [ Time Frame: 1 year ]
 
Descriptive Information
Brief Title  ICMJE SpyGlass in Post Liver Transplant Biliary Complications.
Official Title  ICMJE Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Liver Transplant Disorder
  • Biliary Anastomosis Complication
Intervention  ICMJE Procedure: SpyGlass (direct visualization system) choledochoscopy
SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment
Study Arms  ICMJE 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.
Intervention: Procedure: SpyGlass (direct visualization system) choledochoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02543151
Other Study ID Numbers  ICMJE 1439-11
28005314.5.0000.0071 ( Other Identifier: CONEP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party FERNANDA PRATA MARTINS, Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ANGELO P FERRARI, MD Attending physician
Principal Investigator: FERNANDA P MARTINS, MD Attending physician
PRS Account Hospital Israelita Albert Einstein
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP