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NAFLD Study: US vs Liver Biopsy (NAFLD)

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
shear waves elastography; liver biopsy
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • ICOT LatinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

liver biopsy

ATI

Arm Description

Outcomes

Primary Outcome Measures

diagnostic accurancy of ATI in obese patients
a new ultrasound software compared with liver biopsy in obese patients.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
March 31, 2020
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT04101162
Brief Title
NAFLD Study: US vs Liver Biopsy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liver biopsy
Arm Type
Other
Arm Title
ATI
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
shear waves elastography; liver biopsy
Intervention Description
Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)
Primary Outcome Measure Information:
Title
diagnostic accurancy of ATI in obese patients
Description
a new ultrasound software compared with liver biopsy in obese patients.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANNA GUIDA, medicine
Phone
+393288699401
Email
anna.guida88@gmail.com
Facility Information:
Facility Name
ICOT Latina
City
Latina
State/Province
LT
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Silecchia, medicine
Phone
+3907736511
Email
info@giomi.com

12. IPD Sharing Statement

Plan to Share IPD
No

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NAFLD Study: US vs Liver Biopsy

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