CirrhosisNCT01080144
Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
A study testing Critical flicker frequency procedure in people with Cirrhosis, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Critical flicker frequency procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cirrhosis in whom a TIPS is indicated
- patients have given their informed consent te be included
Who cannot join
- minor
- pregnant women
- patients who cannot see the red color
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
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.
Read more
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
- Being tested
- Critical flicker frequency procedure
- Keywords
- Cirrhosis, TIPS (Transjugular intrahepatic portosystemic shunt), Encephalopathy
- Medical subject headings
- Fibrosis, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical flicker frequency procedureOther
After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Critical Flicker Frequency | Experimental | Critical Flicker Frequency Procedure Receives: Other: Critical flicker frequency procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of Critical Flicker Frequency (CFF) Procedure
number of patients in whom ten measurement will be available / 30 patients
Measured: before TIPS and every 3 months till one year
Secondary outcomes (1)
occurrence of encephalopathy
Measured: every 3 months till one year after TIPS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Bureau, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080144
- Sponsor's protocol ID
- 09 156 02
- Status last verified
- May 2017
- First submitted
- 2 Mar 2010
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24620380
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT01080144
- Acronym / sponsor ID
- 09 156 02
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis, TIPS (Transjugular intrahepatic portosystemic shunt), Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Flicker Frequency | Experimental | Other: Critical flicker frequency procedureCritical Flicker Frequency Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with cirrhosis in whom a TIPS is indicated
- patients have given their informed consent te be included
Key exclusion criteria (4 listed)
- minor
- pregnant women
- patients who cannot see the red color
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical flicker frequency procedureAfter TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months | Other | Critical Flicker Frequency |
Primary outcome
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
1 secondary outcome
occurrence of encephalopathy
Time frame: every 3 months till one year after TIPS procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Results publication: PubMed 24620380Berlioux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Bureau, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical flicker frequency procedure in people with Cirrhosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of Critical Flicker Frequency (CFF) Procedure (time frame: before TIPS and every 3 months till one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.