NAFLD Study: US vs Liver Biopsy

University of Roma La Sapienza

Status: Unknown

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Diagnostic Test: shear waves elastography; liver biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04101162

0109926/2018

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

liver biopsy

Other group

Treatment:

Diagnostic Test: shear waves elastography; liver biopsy

ATI

Other group

Treatment:

Diagnostic Test: shear waves elastography; liver biopsy