Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study (ESCULAP)

University Hospital Erlangen

Status: Completed

Conditions: Liver Neoplasms; Liver Cirrhosis; Hepatocellular Carcinoma; Cholangiocarcinoma, Intrahepatic; Liver Cancer; Liver Diseases

Treatments: Diagnostic Test: MRI; Diagnostic Test: Histology; Diagnostic Test: contrast enhanced ultrasound (CEUS)

Study type: Observational

Funder types: Other

Identifiers

NCT03405909

DEGUM CEUS HCC

Details and patient eligibility

About

Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.

The study is funded by the German Society for Ultrasound in Medicine (DEGUM).

Full description

To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:

1. whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
2. whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
3. diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).

Enrollment: 517 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• high risk for HCC
• focal liver lesion on B-mode ultrasound

Exclusion criteria

• pre-treated HCC lesion
• systemic therapy for HCC (sorafenib, regorafenib and others)

Trial design

517 participants in 1 patient group

Patients at risk for HCC

Description:

Patients with any of the following conditions: liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology

Treatment:

Diagnostic Test: contrast enhanced ultrasound (CEUS)

Diagnostic Test: MRI

Diagnostic Test: Histology