Combination Diagnostic Strategies in NAFLD (CombinationSSI)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease; Non-Alcoholic Fatty 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 Type: Observational
• Enrollment (Actual): 577

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent liver biopsy for the diagnosis of a NAFLD

Description

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

Exclusion criteria:

• Other aetiologies of chronic liver disease
• biopsy length under 10mm

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracyclassification	Diagnostic accuracyclassification	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Christophe Cassinotto, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2011
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Non-invasive diagnosis; NAFLD; Liver fibrosis; Liver elastography
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: RECHMPL20_0281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

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