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

NCT06720766 | Recruiting

• 2 other identifiers: 2023-S-177CSY-YNXM-2023-001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy

  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

  Optimal thresholds for application on people with obesity

  Through study completion, an average of 1 year

Interventions

FibbroScan and biopsy DIAGNOSTIC_TEST

In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Study Sites (1)

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Peisen Guo

CONTACT

+8615803838681; peisenguo@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: October 24, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)