About this trial
Hepatocellular carcinoma (HCC) is a common malignancy in China with a high mortality rate. Its early recurrence and long-term prognosis are closely associated with tumor aggressiveness. Microvascular invasion (MVI), defined as the presence of tumor cells within small branches of the portal or hepatic veins, is a key indicator of malignant biological behavior in HCC. Clinically, MVI is strongly correlated with postoperative early recurrence and serves as an important factor in determining surgical margin extension, adjuvant therapy, and postoperative management strategies.
At present, definitive diagnosis of MVI still relies on postoperative pathological examination, and stable, effective preoperative assessment methods are lacking. Although some studies have attempted to predict MVI using preoperative imaging features, their clinical translation remains limited by poor generalizability, weak interpretability, and insufficient cross-center adaptability.
This study aims to leverage multiphase preoperative CT imaging, artificial intelligence techniques, and clinical prior knowledge to develop a high-performance, generalizable, and interpretable computer-aided diagnostic system for preoperative prediction of HCC-MVI. An observational, prospective evaluation will be conducted to assess system performance and to facilitate the clinical translation of intelligent diagnostic technologies in real-world practice.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Confirmed diagnosis of hepatocellular carcinoma (HCC) according to the Chinese Clinical Practice Guidelines for Primary Liver Cancer.
Eligible for surgical intervention (hepatic resection or liver transplantation) according to the Chinese Clinical Practice Guidelines for Cancer, including stages Ia, Ib, and IIa.
Preoperative imaging examination performed within 1 month before surgery.
Disqualifiers
History of prior antitumor treatment, including preoperative surgical intervention, transarterial chemoembolization (TACE), radiofrequency ablation (RFA), systemic therapy, or any other preoperative intervention.
Presence of major vascular invasion, bile duct invasion/thrombosis, extrahepatic metastasis, or lymph node involvement.
Diffuse hepatocellular carcinoma or tumor rupture with hemorrhage.
Lack of key data required for primary analysis.
Trial design
Treatments tested in this trial
- Computer-Aided Diagnosis System for Preoperative Prediction of MVI in HCC
Treatment groups
19
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Chinese Academy of Sciences
Lead sponsor
Peking Union Medical College Hospital
Collaborator
First Affiliated Hospital of Kunming Medical University
Collaborator
Beijing YouAn Hospital
Collaborator
Zhujiang Hospital
Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Henan Provincial People's Hospital
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Shengjing Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
Yunnan Cancer Hospital
Collaborator
The First People's Hospital of Yunnan
Collaborator
Guizhou Provincial People's Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
West China Hospital
Collaborator
ZhuHai Hospital
Collaborator
Dazhou Central Hospital
Collaborator
Eastern Hepatobiliary Surgery Hospital
Collaborator