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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07600346
Enrollment
105
Registered
2026-05-20
Start date
2026-05-30
Completion date
2027-05-30
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-enhanced Ultrasound, Hepatocellular Carcinoma (HCC) Prognosis

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.

Detailed description

This study is a cross-sectional study.

Interventions

DIAGNOSTIC_TESTContrast-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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Performance as Measured by AUCUp 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026