The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology

Not Applicable

• Conditions: Fatty Liver; NAFLD
• Interventions: Diagnostic Test: ELF Test

• Registration Number: NCT05370053
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Background: During the hepatology evaluation, vibration-controlled transient elastography (VCTE) is often used as a clinical decision aid to target high-risk patients for liver biopsy. The enhanced liver fibrosis (ELF) test is expected to be approved in the US. We tested the hypothesis that making the ELF results available to the treating hepatologist will result in more appropriate and targeted use of liver biopsy in patients with elevated liver enzymes or fatty liver, and will result in more cases of advanced fibrosis/cirrhosis being diagnosed. Methods: During the hepatology evaluation for elevated liver enzymes or fatty liver at the University of Kansas Medical Center, the hepatologists (8 total) make a clinical decision on whether patients shall receive VCTE. At the end of the clinic visit, patients were enrolled and randomized to receiving an ELF test. Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. The primary outcome is the rate of a diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis with the initiation of hepatocellular carcinoma surveillance. Four hundred fifty patients are to be enrolled over two years.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-06-24
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients from hepatology clinic undergoing new evaluation for NAFLD.

Exclusion Criteria

• Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. Patients known to have other liver diseases were also excluded. Patients consuming > 14 drinks in the past 6 months were excluded. Patients may be subsequently found to have positive viral or autoimmune serologies after enrollment because the serology result is typically not available at the time of enrollment. These patients will be excluded from the analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELF-test	ELF Test	Patients receive ELF testing (a blood draw) and their hepatologist receives the result within a week.

Primary Outcome Measures

Name	Time	Method
A diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis.	2 years	The number of patients diagnosed with stage 3-4 based on liver biopsy or clinical diagnosis of cirrhosis in each arm of the study.; Clinical diagnosis of cirrhosis is defined as provider diagnosing cirrhosis and ordering of hepatocellular carcinoma surveillance.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States