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NCT Number: NCT07600346

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

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.

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Key information

About this study

This study is a cross-sectional study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic Performance as Measured by AUC

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

    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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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