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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contrast-Enhanced Ultrasound.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC) Prognosis, Contrast-enhanced Ultrasound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study is a cross-sectional study.
Interventions
- Diagnostic test Contrast-Enhanced Ultrasound
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 outcome measures
- Diagnostic Performance as Measured by AUC [Time frame: Up to 1 month after the enrollment and data collection completion.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07600346 · 2026-MS-241