Hepatic carcinoma
Conditions
Interventions
Gold Standard:The reference standard is the final postoperative routine pathological H&E diagnosis of microvascular invasion (MVI) status. Surgical specimens are processed by standard formalin fixatio
Index test:The index tests are femtosecond label-free imaging (FLI) and AI-assisted FLI interpretation. FLI uses femtosecond pulsed laser excitation of endogenous fluorescence and nonlinear optical si
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Preoperative clinical diagnosis or imaging examination indicates HCC, and planned to undergo radical liver resection; 3. After surgical resection, it is expected to obtain fresh tumor and tumor-non-tumor junctional tissue for FLI imaging; 4. Within 30 minutes after the surgical specimen is removed from the body, standardized sampling from the tumor-non-tumor junction can be completed; 5. Post-surgery, routine pathological H&E diagnosis can be performed to obtain the final MVI status; 6. Can provide written informed consent and cooperate with the research process.
Exclusion criteria
Exclusion criteria: 1. Postoperative pathological diagnosis of non-HCC (such as intrahepatic cholangiocarcinoma, mixed-type liver cancer, focal nodular hyperplasia, etc.); 2. Unable to obtain qualified fresh tissue specimens (such as delayed sampling, insufficient tissue volume, or inability to identify the tumor-non-tumor boundary); 3. Insufficient image quality of FLI, confirmed as unassessable after quality review; 4. Lack of final pathological MVI status (such as incomplete pathological report); 5. Patients who have received preoperative treatments or neoadjuvant therapies that significantly affect the judgment of tissue morphology; 6. Complicated with other malignant tumors that may interfere with pathological judgment; 7. Other situations deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of FLI reading for MVI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the three reading modes for MVI;Sensitivity and specificity of each reading mode for MVI;Positive and negative predictive values of each reading mode for MVI;AUC of each reading mode for MVI diagnosis;Incremental diagnostic value of AI-assisted FLI reading over FLI reading;Inter-reader agreement under different reading modes;Reading time under different reading modes;FLI image evaluability; | — |
Countries
China
Contacts
Public ContactFeng Shen
Clinical Research Institute, Eastern Hepatobiliary Surgery Hospital and National Center for Liver Cancer, Naval Medical University
Outcome results
None listed