NCT05370053

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatty Liver
• NAFLD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ELF Test	Patients receive ELF testing (a blood draw) and their hepatologist receives the result within a week.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-05-11
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States