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Completed

NCT Number: NCT01080144

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

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

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Key information

Conditions

Cirrhosis Brain Diseases Central Nervous System Diseases Fibrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Christophe Bureau

Toulouse, Hôpital Rangueil, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Critical flicker frequency procedure

Other

After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months

Primary outcomes

  1. 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 outcomes

  1. occurrence of encephalopathy

    Time frame: every 3 months till one year after TIPS procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2010
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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