CombinationSSI: Combination Diagnostic Strategies in NAFLD

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04384159

Collaborator

(none)

577

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Serial combination of biological and elastography tests is accurate to diagnosing advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) patients. In this study, the investigators compared the diagnostic performances of a 2-step strategy using either vibration-controlled transient elastography (VCTE) or bidimensional shear wave elastography with Supersonic imagine (2D-SWE-SSI), and analysed the added-value of a 3-step strategy.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease Chronic Liver Disease

Detailed Description

The investigators retrospectively selected all consecutive adult patients with suspicion of NAFLD who had undergone liver biopsy from November 2011 to July 2019 in 2 French academic centers, Angers and Bordeaux university hospitals. A total of 577 patients were included. Among them, 291 had been previously included in a prospective study comparing diagnostic performances of several non-invasive tests in NAFLD patients. Inclusion criteria were: Age≥18yo, 2D-SWE-SSI and VCTE performed within the two weeks prior to liver biopsy. Exclusion criteria were high alcohol consumption (i.e., >21 drinks, on average, per week in men and >14 drinks, on average, per week in women), associated causes of liver disease (alcoholic, viral, or other causes of liver injury), other aetiologies than NAFLD on pathological examination, and a liver biopsy length of less than 10 mm and/or fewer than 6 portal spaces and/or more than 2 fragments, except for in cases of cirrhosis.

Study Design

Study Type:

Observational

Actual Enrollment :

577 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Transient Versus Bidimensional Shear Wave Elastography in Serial Combination Strategy to Diagnose Advanced Fibrosis in NAFLD Patients

Actual Study Start Date :

Nov 30, 2011

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 31, 2019

Outcome Measures

Primary Outcome Measures

Diagnostic accuracyclassification [1 day]
Diagnostic accuracyclassification

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

PAtients who underwent a liver biopsy for a suspicion of NAFLD, and liver stiffness evaluation with either Fiborscan and Bidimensional shear wave elastography