Status:
UNKNOWN
NAFLD Study: US vs Liver Biopsy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04101162
Start Date
September 15 2019
End Date
December 15 2020
Last Update
April 1 2020
Active Locations (1)
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1
ICOT Latina
Latina, LT, Italy, 04100