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

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Other: Critical flicker frequency procedure

• Registration Number: NCT01080144
• Lead Sponsor: University Hospital, Toulouse

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Critical Flicker Frequency	Critical flicker frequency procedure	Critical Flicker Frequency Procedure

Primary Outcome Measures

Name	Time	Method
success rate of Critical Flicker Frequency (CFF) Procedure	before TIPS and every 3 months till one year	number of patients in whom ten measurement will be available / 30 patients

Secondary Outcome Measures

Name	Time	Method
occurrence of encephalopathy	every 3 months till one year after TIPS procedure

Trial Locations

Locations (1)

Dr Christophe Bureau; 🇫🇷 Toulouse, Hôpital Rangueil, France