Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Contrast-enhanced Ultrasound | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) Prognosis | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Performance as Measured by AUC
- timeFrame
- Up to 1 month after the enrollment and data collection completion.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available