NCT04101162

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

September 5, 2019

Last Update Submit

March 31, 2020

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • diagnostic accurancy of ATI in obese patients

    a new ultrasound software compared with liver biopsy in obese patients.

    6 months

Study Arms (2)

liver biopsy

OTHER
Diagnostic Test: shear waves elastography; liver biopsy

ATI

OTHER
Diagnostic Test: shear waves elastography; liver biopsy

Interventions

shear waves elastography; liver biopsyDIAGNOSTIC_TEST

Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)

ATIliver biopsy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICOT Latina

Latina, LT, 04100, Italy

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

ANNA GUIDA, medicine

CONTACT

+393288699401anna.guida88@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 24, 2019

Study Start

September 15, 2019

Primary Completion

October 15, 2020

Study Completion

December 15, 2020

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)