Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01695083
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2012-09-25
Brief Title:
Non Invasive Measurements of Fibrosis Inflammation and Steatohepatitis in Morbidly Obese Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Non Invasive Measurements of Fibrosis Inflammation and Steatohepatitis in Morbidly Obese Patients
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRM
Brief Summary:
Abstract
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
Methodology
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
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
Methodology
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
Detailed Description:
Main objective
The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery the accuracy of non-invasive tests for diagnosis of severe steatosis and or NASH
The gold standard is liver biopsy with a morphometric study
Non-invasive tests will be used
Serum tests the FibroMax which includes the NASH test FibroTest and SteatoTest and FibroMeter
Radiological examinations MRI and FibroScan CAP
Secondary objectives
The secondary objectives are
1 to determine the accuracy of these non-invasive tests for the diagnosis of severe steatosis alone steatohepatitis NASH or and hepatic fibrosis
2 to determine the best combination of these tests to better evaluate the presence of severe steatosis NASH and a hepatic fibrosis
3 to quantify MRI visceral and subcutaneous fat in morbidly obese patients
Research Design
1 Judging Criteria
Primary endpoint 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 The gold standard is the result of histology on liver biopsy with a morphometric study For each diagnostic test a ROC curve is used to determine the best compromise between sensitivity and specificity
The histological diagnosis of severe steatosis is defined by the presence of hepatic steatosis grade 3 or higher The diagnosis of NASH is defined by the presence of lobular inflammation with neutrophils and hepatocytes ballooning
Secondary endpoints
- 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 from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal
2 Methodology and expected number of patients in research
This is a prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients The MRI system open allows access to obese patients Three such systems are available in France and liver pathology is supported only on the system of Louis Mourier
The reference method is liver histology tests studied are MRI abdominal Fibroscan CAP and serum tests FibroTest FibroMeter SteatoTest NASH test
The study will be conducted in 200 obese patients who will have a liver biopsy performed during bariatric surgery
Tests for the detection of steatosis fat quantification of intrahepatic MRI measurement of steatosis by CAP serum tests and evaluating histological steatosis main objective
Tests for the detection of NASH test serum and histology
Tests of fibrosis serum tests FibroScan and histological data assessing fibrosis
The duration and extent of obesity BMI and biological data HOMA-test will be taken into account
3 Examinations required specifically for research
Liver biopsy is routinely performed intraoperatively in the routine monitoring of patients for bariatric surgery examinations specific to the research are
Serum tests
FibroScan CAP
Abdominal MRI
Risk risk absences The sting at blood sampling can cause the formation of a small hematoma without gravity which will subside spontaneously within a few days
FibroScan CAP presents no risk of side effects Liver MRI shows no risk if the cons-indications are respected Wearing a stack pacemaker or any element that contains the iron near the eyes or head are contra-indications as are a major risk factor risk of death blindness The presence of a heart valve or a stent also called metal prosthesis is not an absolute contra-indication-and their compatibility with MRI will be verified before completion of the examination as is the case in practice clinic
Liver biopsy which is part of the examinations carried out in a systematic way without any protocol adds no additional risk to the surgical
4 Study site
The study will be conducted at Louis Mourier a reference center for the treatment of obesity which has an open system allowing access to obese
5 Indications for bariatric surgery
Indications for bariatric surgery at Louis Mourier a reference center for the treatment of obesity are consistent with the recommendations of the HAS in 2009 based on professional consensus
Surgery is indicated in patients with all of the following criteria
1 BMI 40 or BMI 35 with comorbid
2 failure s prior s of the conventional treatment of obesity combined dietary physical activity and behavioral therapy
3 appraisal nutritionally global personal and non-surgical
4 considered only after medical treatment for a minimum of 1 year
5 well-informed and motivated patients with acceptable surgical risks
6 obesity stable or worsening for five years
7 absence of endocrine pathology adrenal thyroid may be due to obesity
The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery the accuracy of non-invasive tests for diagnosis of severe steatosis and or NASH
The gold standard is liver biopsy with a morphometric study
Non-invasive tests will be used
Serum tests the FibroMax which includes the NASH test FibroTest and SteatoTest and FibroMeter
Radiological examinations MRI and FibroScan CAP
Secondary objectives
The secondary objectives are
1 to determine the accuracy of these non-invasive tests for the diagnosis of severe steatosis alone steatohepatitis NASH or and hepatic fibrosis
2 to determine the best combination of these tests to better evaluate the presence of severe steatosis NASH and a hepatic fibrosis
3 to quantify MRI visceral and subcutaneous fat in morbidly obese patients
Research Design
1 Judging Criteria
Primary endpoint 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 The gold standard is the result of histology on liver biopsy with a morphometric study For each diagnostic test a ROC curve is used to determine the best compromise between sensitivity and specificity
The histological diagnosis of severe steatosis is defined by the presence of hepatic steatosis grade 3 or higher The diagnosis of NASH is defined by the presence of lobular inflammation with neutrophils and hepatocytes ballooning
Secondary endpoints
- 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 from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal
2 Methodology and expected number of patients in research
This is a prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients The MRI system open allows access to obese patients Three such systems are available in France and liver pathology is supported only on the system of Louis Mourier
The reference method is liver histology tests studied are MRI abdominal Fibroscan CAP and serum tests FibroTest FibroMeter SteatoTest NASH test
The study will be conducted in 200 obese patients who will have a liver biopsy performed during bariatric surgery
Tests for the detection of steatosis fat quantification of intrahepatic MRI measurement of steatosis by CAP serum tests and evaluating histological steatosis main objective
Tests for the detection of NASH test serum and histology
Tests of fibrosis serum tests FibroScan and histological data assessing fibrosis
The duration and extent of obesity BMI and biological data HOMA-test will be taken into account
3 Examinations required specifically for research
Liver biopsy is routinely performed intraoperatively in the routine monitoring of patients for bariatric surgery examinations specific to the research are
Serum tests
FibroScan CAP
Abdominal MRI
Risk risk absences The sting at blood sampling can cause the formation of a small hematoma without gravity which will subside spontaneously within a few days
FibroScan CAP presents no risk of side effects Liver MRI shows no risk if the cons-indications are respected Wearing a stack pacemaker or any element that contains the iron near the eyes or head are contra-indications as are a major risk factor risk of death blindness The presence of a heart valve or a stent also called metal prosthesis is not an absolute contra-indication-and their compatibility with MRI will be verified before completion of the examination as is the case in practice clinic
Liver biopsy which is part of the examinations carried out in a systematic way without any protocol adds no additional risk to the surgical
4 Study site
The study will be conducted at Louis Mourier a reference center for the treatment of obesity which has an open system allowing access to obese
5 Indications for bariatric surgery
Indications for bariatric surgery at Louis Mourier a reference center for the treatment of obesity are consistent with the recommendations of the HAS in 2009 based on professional consensus
Surgery is indicated in patients with all of the following criteria
1 BMI 40 or BMI 35 with comorbid
2 failure s prior s of the conventional treatment of obesity combined dietary physical activity and behavioral therapy
3 appraisal nutritionally global personal and non-surgical
4 considered only after medical treatment for a minimum of 1 year
5 well-informed and motivated patients with acceptable surgical risks
6 obesity stable or worsening for five years
7 absence of endocrine pathology adrenal thyroid may be due to obesity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-A00829-32 | REGISTRY | ANSM | None |