SteatosisNCT03548597
Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery
An observational study of Steatosis and Obesity, run by European Georges Pompidou Hospital.
Trial summary
Background: The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients. Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Steatosis, Obesity, Fibrosis, Liver
- What is being tested?
- Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2012to 6 Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Severe obese patients candidate to bariatric surgery
Who may be able to join
- Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.
Who cannot join
None listed.
About this study
Official title: Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
Background:
The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.
Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.
Objectives:
Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.
- Conditions
- Steatosis, Obesity, Fibrosis, Liver
- Being tested
- Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
- Medical subject headings
- Fatty Liver, Obesity, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric SurgeryDevice
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity measured with the Fibroscan XL
Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned.
Measured: 3 years
Secondary outcomes (1)
53/5000 Evolution of elasticity after bariatric surgery
The evolution of elasticity will be measured non-invasively with fibroscan after bariatric surgery. NO adverse effects are expected in relation to this measure.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start4 Apr 2012
- Primary completion12 Jan 2015
- Study completion6 Dec 2016
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 SteatosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Echosens
- Responsible party
- Principal investigator, Charles Barsamian, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548597
- Sponsor's protocol ID
- B047
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barsamian C, Carette C, Sasso M, Poghosyan T, Bedossa P, Emile JF, Parlier D, Miette V, Bouillot JL, Czernichow S, Rives-Lange C. Diagnostic of hepatic fibrosis with the XL probe of the Fibroscan versus biopsies in patients candidates to bariatric surgery. Clin Nutr ESPEN. 2020 Jun;37:226-232. doi: 10.1016/j.clnesp.2020.02.010. Epub 2020 Mar 12.
PubMed 32359748
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03548597
- Acronym / sponsor ID
- B047
- Conditions
- Steatosis, Obesity, Fibrosis, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Collaborators
- Echosens
- Study start
- 4 Apr 2012 (actual)
- Primary completion
- 12 Jan 2015 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 7 Jun 2018 (actual)
- 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.
Background:
The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.
Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.
Objectives:
Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Severe obese patients candidate to bariatric surgery
Key inclusion criteria (1 listed)
- Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric SurgeryEvaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery | Device | – |
Primary outcome
Elasticity measured with the Fibroscan XL
Time frame: 3 years
Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned.
1 secondary outcome
53/5000 Evolution of elasticity after bariatric surgery
Time frame: 3 years
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 7 Jun 2018.
- Derived from this study: PubMed 32359748Barsamian C, Carette C, Sasso M, Poghosyan T, Bedossa P, Emile JF, Parlier D, Miette V, Bouillot JL, Czernichow S, Rives-Lange C. Diagnostic of hepatic fibrosis with the XL probe of the Fibroscan versus biopsies in patients candidates to bariatric surgery. Clin Nutr ESPEN. 2020 Jun;37:226-232. doi: 10.1016/j.clnesp.2020.02.010. Epub 2020 Mar 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatosis and Obesity, run by European Georges Pompidou Hospital.
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 1 inclusion and 0 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Elasticity measured with the Fibroscan XL (time frame: 3 years). 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 NCT03548597, 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 7 Jun 2018.