Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity (MASLD)

December 2, 2024 updated by: Hongmei Zhu, The Third People's Hospital of Chengdu

The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.

The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.

Study Overview

Status

Recruiting

Conditions

Fatty Liver Disease

Intervention / Treatment

Diagnostic test: FibbroScan and biopsy

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Peisen Guo
Phone Number: +8615803838681
Email: peisenguo@163.com

Study Locations

China
- Sichuan
  - Chengdu, Sichuan, China
    - Recruiting
    - The Third People's Hospital of Chengdu
    - Contact:
      
      Jiahui Yu
      
      Email: dr_jiahuiyu@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.

Description

Inclusion Criteria:

Patients aged 18 years or older who provided written informed consent
Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
Patients who schedule to undergo FibroScan examination

Exclusion Criteria:

Patients with ascites or pregnant women
Patients with any active implantable medical device (such as a pacemaker or defibrillator)
Patients who have undergone liver transplantation
Patients with cardiac failure and/or significant valvular disease
Patients with haemochromatosis
Patients who have refused to undergo LB or blood tests
Patients with a confirmed diagnosis of active malignancy, or other terminal disease
Patients participating in another clinical trial within the preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy Time Frame: Through study completion, an average of 1 year	Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis	Through study completion, an average of 1 year
Cut-off values Time Frame: Through study completion, an average of 1 year	Optimal thresholds for application on people with obesity	Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third People's Hospital of Chengdu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)