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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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This retrospective observational study aims to evaluate whether artificial intelligence (AI) models can predict aggressive recurrence in patients who underwent liver resection for early-stage hepatocellular carcinoma (HCC). The main question it seeks to answer is:
Can deep learning models combining preoperative MRI, postoperative pathology slides, and clinical data accurately identify HCC patients at high risk of aggressive recurrence after surgery?
To answer this, the investigators will analyze existing medical data (preoperative MRIs, postoperative whole-slide images, and clinical records) from 579 patients across two medical centers. All data will be anonymized before analysis, and no additional interventions are required from participants.
This study may help clinicians stratify high-risk patients who could benefit from closer surveillance or adjuvant therapies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ Cohort (Training/Validation) | Internal cohort from Tongji Hospital (2018-2021) used for model training and validation. Includes 462 patients with early-stage HCC who underwent curative resection. Data: preoperative MRI, clinical variables, and postoperative pathology slides. No interventions beyond standard care. |
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| SYSMH Cohort (External Test) | Independent external test cohort from Sun Yat-sen Memorial Hospital (2021-2022). Includes 117 patients with early-stage HCC meeting identical inclusion criteria. Used to validate generalizability of multimodal DL models. Data anonymized; no additional interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liver resection | Procedure | This is a retrospective observational study analyzing existing clinical data; no experimental interventions were administered. The study evaluates the predictive performance of two deep learning models (preoperative and postoperative) using standard-of-care medical data collected during routine clinical practice, including: Preoperative contrast-enhanced MRI scans Postoperative hematoxylin and eosin (H&E)-stained whole slide images Clinical variables (laboratory results, pathology reports, and demographic data) All data were collected as part of standard diagnostic and treatment protocols for hepatocellular carcinoma (HCC) patients undergoing liver resection. No additional interventions or modifications to clinical care were implemented for study purposes. The artificial intelligence models were applied to previously acquired, de-identified data to predict aggressive recurrence patterns |
| Measure | Description | Time Frame |
|---|---|---|
| Aggressive Recurrence Pattern | Defined as first recurrence exceeding Milan criteria within 2 years after liver resection. | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | Time from surgery date to radiologically confirmed recurrence or last follow-up (until July 30, 2024). | From surgery until first recurrence or July 30, 2024 |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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This retrospective multicenter study analyzed 579 patients with early-stage hepatocellular carcinoma (HCC) who underwent curative liver resection at two tertiary academic medical centers in China. The study population consisted of:
Primary Cohort (Training/Validation):
462 patients from Tongji Hospital (2018-2021)
External Test Cohort:
117 patients from Sun Yat-sen Memorial Hospital (2021-2022) All patients met strict inclusion criteria: curative (R0) resection, preoperative MRI within 1 month before surgery, available postoperative pathology slides, and complete follow-up. The population represents typical early-stage HCC patients eligible for surgical resection in endemic areas.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D006498 | Hepatectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Time from surgery date to death from any cause or last follow-up.
| From surgery until death or July 30, 2024 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |