- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080144
Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hôpital Rangueil
-
Toulouse, Hôpital Rangueil, France, 31000
- Dr Christophe Bureau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Critical Flicker Frequency
Critical Flicker Frequency Procedure
|
After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate of Critical Flicker Frequency (CFF) Procedure
Time Frame: before TIPS and every 3 months till one year
|
number of patients in whom ten measurement will be available / 30 patients
|
before TIPS and every 3 months till one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
occurrence of encephalopathy
Time Frame: every 3 months till one year after TIPS procedure
|
every 3 months till one year after TIPS procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Bureau, MD, University Hospital, Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09 156 02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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