Clinical trial NCT03872024: Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients
Official title: Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients - NEO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Liver Fibrosis
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes.

Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications.

The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome.

Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP).

Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD.

However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI≥35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years old
* Patient must be able to give written informed consent
* Patient affiliated to a social security system
* Patients participating in the standard bariatric surgery care program (bariatric surgery criteria defined with BMI ≥ 40 kg / m² or patients with BMI ≥ 35 kg / m² and at least 1 associated co-morbidity

Exclusion Criteria:

* Patient with presence of ascites
* Patients with exclusion criteria for bariatric surgery

Primary outcomes:
measure: Liver biopsy: fibrosis stage from F0 to F4 with Kleiner (NASH CRN) scoring system
timeFrame: 12 months
Secondary outcomes:
measure: Number of valid measurements per probe higher than 8
timeFrame: 12 months
measure: Liver Stiffness Measurement (LSM) from 1.5 to 75 kPa assessed with the FibroScan
timeFrame: 12 months
measure: Controlled Attenuation Parameter (CAP) from 100 to 400 dB/m, assessed with the FibroScan
timeFrame: 12 months
measure: Liver biopsy: steatosis grade from S0 to S3 with Kleiner (NASH CRN) scoring system
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital la Pitié Salpêtrière
Study officials:
References: