A Comparative Study on the Diagnostic Efficacy of Ultrasound Contrast LI-RADS Grading and the German ESCULAP Standards for the Diagnosis of Recurrent Hepatic Mass Lesions After Hepatocellular Carcinoma Surgery

NCT07600346 | Not Yet Recruiting

• 1 other identifier: 2026-MS-241
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most common malignant tumor worldwide, with a significantly increased incidence among patients with liver diseases. Even if HCC can be treated by surgical resection and ablation, the 5-year recurrence rate is as high as 50-70%. The Liver Imaging Reporting and Data System (LI-RADS), released by the American College of Radiology (ACR), is a classification management system specifically designed to evaluate liver lesions in high-risk HCC patients. Since its release in 2011, the CT/MRI LI-RADS has been updated to the 2018 version. Subsequently, the CEUS LI-RADS was introduced in 2016 and updated in 2017. The CEUS LI-RADS standard has relatively high specificity but lacks sensitivity. The ESCULAP (Erlanger Synopsis of Contrast-enhanced Ultrasound for Liver lesion Assessment in Patients at Risk) standard proposed by Schellhaas et al. in Germany has high sensitivity in diagnosing HCC in patients with liver diseases . However, there is currently a lack of research on the diagnostic efficacy of these two standards for the re-discovery of liver space-occupying lesions in patients with a history of HCC. This study aims to compare the diagnostic efficacy of the two standards for recurrent HCC in patients with a history of HCC.

Conditions

Hepatocellular Carcinoma (HCC) Prognosis; Contrast-enhanced Ultrasound

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance as Measured by AUC

  The Area Under the Receiver Operating Characteristic curve (AUC) of CEUS LI-RADS LR-5 versus the Erlanger criteria for diagnosing recurrent HCC, using histopathology or composite clinical follow-up as the reference standard. Comparison will be performed using the DeLong test.

  Up to 1 month after the enrollment and data collection completion.

Interventions

Contrast-Enhanced Ultrasound DIAGNOSTIC_TEST

The contrast-enhanced ultrasound technique, by injecting the contrast agent through the basilic vein, enables real-time and dynamic observation of the blood flow perfusion of liver lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of outpatients and inpatients who visit the Department of Abdominal Ultrasound at First Hospital of Jilin University and undergo liver contrast-enhanced ultrasound between May 2026 and May 2027.

You may qualify if:

• (1) At least 18 years old; (2) Has a previous history of liver cell cancer surgery or ablation, and has a newly developed liver lesion this time; (3) The new lesion completed a complete contrast-enhanced ultrasound examination within two weeks before the final diagnosis, and the dynamic imaging data is completely preserved; (4) The new lesion has a clear pathological or clinical diagnosis.

You may not qualify if:

• (1) The quality of contrast-enhanced ultrasound images is poor, making it impossible to assess the critical phases; (2) New lesions that have been treated locally or systemically.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ,PI

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05