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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
History of Changes
  Purpose

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

Condition Intervention
Cirrhosis
 Other: Critical flicker frequency procedure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • occurrence of encephalopathy [ Time Frame: every 3 months till one year after TIPS procedure ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Critical Flicker Frequency
Critical Flicker Frequency Procedure
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080144

Locations
France
Dr Christophe Bureau
Toulouse, Hôpital Rangueil, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Christophe Bureau, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01080144     History of Changes
Other Study ID Numbers: 09 156 02
Study First Received: March 2, 2010
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Cirrhosis
TIPS (Transjugular intrahepatic portosystemic shunt)
Encephalopathy

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013