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

NCT01080144 | Completed

• 1 other identifier: 09 156 02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cirrhosis

Keywords

Cirrhosis; TIPS (Transjugular intrahepatic portosystemic shunt); Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• occurrence of encephalopathy

  every 3 months till one year after TIPS procedure

Study Arms (1)

Critical Flicker Frequency

EXPERIMENTAL

Critical Flicker Frequency Procedure

Other: Critical flicker frequency procedure

Interventions

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

Critical Flicker Frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cirrhosis in whom a TIPS is indicated
• patients have given their informed consent te be included

You may not qualify if:

• minor
• pregnant women
• patients who cannot see the red color
• refusal to participate

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Dr Christophe Bureau

Toulouse, Hôpital Rangueil, 31000, France

Location

Related Publications (1)

• Berlioux P, Robic MA, Poirson H, Metivier S, Otal P, Barret C, Lopez F, Peron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more accurate than psychometric tests. Hepatology. 2014 Feb;59(2):622-9. doi: 10.1002/hep.26684.

  PMID: 24620380 RESULT

MeSH Terms

Conditions

Fibrosis; Brain Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christophe Bureau, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

FR (1)