Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients (FIRM)
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|ClinicalTrials.gov Identifier: NCT01695083|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : June 1, 2017
Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications.
Number of subjects required:
According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital.
Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month.
It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier.
The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests.
Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests.
Primary endpoint :
To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity.
The secondary endpoints were:
Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal
|Condition or disease|
|Morbid Obesity Non Alcoholic Steatohepatitis|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
- To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values) [ Time Frame: 3 months ]serum tests, FibroScan/CAP abdominal MRI
- Histological lesions of liver fibrosis and quantification of abdominal fat by MRI [ Time Frame: 3 months ]quantification of abdominal fat by MRI in the form of three variables of interest: quantification of the surface of the visceral fat from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695083
|Hôpital Louis Mourier|
|Colombes, France, 92700|
|Principal Investigator:||Pauline Jouët, MD||Assistance Publique - Hôpitaux de Paris|