Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
Evaluate the diagnostic accuracy of the new ultrasound software vs hepatic histology, the current reference standard for the diagnosis of NAFLD and NASH in 20 obese patients (BMI\> 30) candidates for laparoscopic bariatric surgery and / or cholecystectomy
Interventions
DIAGNOSTIC_TESTshear waves elastography; liver biopsy
Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who are candidates for bariatric surgery between the ages of 18 and 65, * BMI\> 40 kg / m2, in the absence of any other comorbidity * BMI\> 35 kg / m2, in the presence of comorbidities among those classically considered to be associated with obesity * ICM\> 30 kg / m2, in the presence of T2DM not in glycometabolic compensation 2. Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI\> 30
Exclusion criteria
* Age ≤ 18 or ≥ 65 * Any concurrent surgical procedure except cholecystectomy and hiatal hernia repair * Conversion into laparotomy surgery * Post-operative complications requiring new surgical treatment * Patient not compliant in the follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accurancy of ATI in obese patients | 6 months | a new ultrasound software compared with liver biopsy in obese patients. |
Countries
Italy
Contacts
Primary ContactANNA GUIDA, medicine
Outcome results
None listed