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

Toulouse University Hospital

Status: Completed

Conditions: Cirrhosis

Treatments: Other: Critical flicker frequency procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01080144

09 156 02

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Critical Flicker Frequency

Experimental group

Description:

Critical Flicker Frequency Procedure

Treatment:

Other: Critical flicker frequency procedure