NAFLD Study: US vs Liver Biopsy (NAFLD)

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

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

Study Overview

• Status: Unknown
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: shear waves elastography; liver biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • LT
    • Latina, LT, Italy, 04100
      • Recruiting
      • ICOT Latina
      • Contact: Gianfranco Silecchia, medicine; Phone Number: +3907736511; Email: info@giomi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: liver biopsy	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)
Other: ATI	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accurancy of ATI in obese patients	a new ultrasound software compared with liver biopsy in obese patients.	6 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 0109926/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No