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

NCT01080144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-11

No results posted yet for this study

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

Conditions

  • Cirrhosis

Interventions

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

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christophe Bureau, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080144 on ClinicalTrials.gov