Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01080144
First received: March 2, 2010
Last updated: January 22, 2013
Last verified: January 2013

March 2, 2010
January 22, 2013
October 2009
October 2012   (final data collection date for primary outcome measure)
success rate of Critical Flicker Frequency (CFF) Procedure [ Time Frame: before TIPS and every 3 months till one year ] [ Designated as safety issue: No ]
number of patients in whom ten measurement will be available / 30 patients
Same as current
Complete list of historical versions of study NCT01080144 on ClinicalTrials.gov Archive Site
occurrence of encephalopathy [ Time Frame: every 3 months till one year after TIPS procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cirrhosis
Other: 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
Experimental: Critical Flicker Frequency
Critical Flicker Frequency Procedure
Intervention: Other: Critical flicker frequency procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01080144
09 156 02
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Christophe Bureau, MD University Hospital, Toulouse
University Hospital, Toulouse
January 2013

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