Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Critical flicker frequency procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Cirrhosis focused on measuring Cirrhosis, TIPS (Transjugular intrahepatic portosystemic shunt), Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- patients with cirrhosis in whom a TIPS is indicated
- patients have given their informed consent te be included
Exclusion Criteria:
- minor
- pregnant women
- patients who cannot see the red color
- refusal to participate
Sites / Locations
- Dr Christophe Bureau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Critical Flicker Frequency
Arm Description
Critical Flicker Frequency Procedure
Outcomes
Primary Outcome Measures
success rate of Critical Flicker Frequency (CFF) Procedure
number of patients in whom ten measurement will be available / 30 patients
Secondary Outcome Measures
occurrence of encephalopathy
Full Information
NCT ID
NCT01080144
First Posted
March 2, 2010
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01080144
Brief Title
Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
Official Title
A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months.
30 patients will be included.
The main endpoint is the success rate of CFF. The secondary end points are
Correlation between CFF and PHES score
Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure
A sample collection during TIPS procedure is also performed for validation of biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Cirrhosis, TIPS (Transjugular intrahepatic portosystemic shunt), Encephalopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Critical Flicker Frequency
Arm Type
Experimental
Arm Description
Critical Flicker Frequency Procedure
Intervention Type
Other
Intervention Name(s)
Critical flicker frequency procedure
Intervention Description
After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months
Primary Outcome Measure Information:
Title
success rate of Critical Flicker Frequency (CFF) Procedure
Description
number of patients in whom ten measurement will be available / 30 patients
Time Frame
before TIPS and every 3 months till one year
Secondary Outcome Measure Information:
Title
occurrence of encephalopathy
Time Frame
every 3 months till one year after TIPS procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with cirrhosis in whom a TIPS is indicated
patients have given their informed consent te be included
Exclusion Criteria:
minor
pregnant women
patients who cannot see the red color
refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Bureau, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Christophe Bureau
City
Toulouse
State/Province
Hôpital Rangueil
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24620380
Citation
Berlioux P, Robic MA, Poirson H, Metivier S, Otal P, Barret C, Lopez F, Peron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more accurate than psychometric tests. Hepatology. 2014 Feb;59(2):622-9. doi: 10.1002/hep.26684.
Results Reference
result
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Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
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