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NCT04101162 Clinical Trial

NAFLD Study: US vs Liver Biopsy

Non-Alcoholic Fatty Liver Disease Clinical Trial

— NAFLD  

Official title:
Diagnostic Accuracy in a New Ultrasound Software Compared to Histology for Non Alcoholic Fatty Liver Disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH) in Morbidly Obese Individuals Undergoing Bariatic Surgery and/or Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04101162
Other study ID # 0109926/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date December 15, 2020

Study information
Verified date March 2020
Source University of Roma La Sapienza
Contact ANNA GUIDA, medicine
Phone +393288699401
Email anna.guida88@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 15, 2020
Est. primary completion date October 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• shear 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)

Locations
Country Name City State
Italy ICOT Latina Latina LT

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accurancy of ATI in obese patients a new ultrasound software compared with liver biopsy in obese patients. 6 months
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