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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080144
First Posted: March 3, 2010
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
University Hospital, Toulouse
  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: None (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:


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 ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01080144     History of Changes
Other Study ID Numbers: 09 156 02
First Submitted: March 2, 2010
First Posted: March 3, 2010
Last Update Posted: May 11, 2017
Last Verified: May 2017

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

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