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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080144
• Other study ID #: 09 156 02
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: May 10, 2017
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
France	Dr Christophe Bureau	Toulouse	Hôpital Rangueil

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Berlioux P, Robic MA, Poirson H, Métivier S, Otal P, Barret C, Lopez F, Péron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more ac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of Critical Flicker Frequency (CFF) Procedure	number of patients in whom ten measurement will be available / 30 patients	before TIPS and every 3 months till one year
Secondary	occurrence of encephalopathy		every 3 months till one year after TIPS procedure