NAFLD Study: US vs Liver Biopsy
Not Applicable
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Diagnostic Test: shear waves elastography; liver biopsy
- Registration Number
- NCT04101162
- Lead Sponsor
- University of Roma La Sapienza
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATI shear waves elastography; liver biopsy - liver biopsy shear waves elastography; liver biopsy -
- Primary Outcome Measures
Name Time Method diagnostic accurancy of ATI in obese patients 6 months a new ultrasound software compared with liver biopsy in obese patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ICOT Latina
🇮🇹Latina, LT, Italy