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The investigators intend to perform a prospective, multicenter study to establish a set of clinical criteria for surgical stages of liver cirrhosis, which can be implemented to guide the surgical treatment of hepatocellular carcinoma (HCC).
HCC is the fifth most common malignancy in the world and ranks the third leading cause of tumor-related mortality. In China, more than 80% of HCC patients are accompanied by liver cirrhosis. Varied degrees of cirrhosis not only play an important role in selecting appropriate operative interventions for HCC patients, but are closely associated with tumor recurrence and long-term survival as well. Therefore, evaluating cirrhotic severity is essential for individualizing surgical modalities and predicting outcomes for patients with HCC. In recent years, investigators' group has proposed to stage the severity of liver cirrhosis through intraoperative liver morphological changes and preoperative cirrhotic severity scoring (TJ-CSS) model. Although the morphological classification of liver cirrhosis is of guiding significance for surgeons to determine the extent of hepatectomy, this method has some defects, such as subjectivity, lack of specific quantitative indicators and so on. Based on this, investigators propose to evaluate the severity of liver cirrhosis by measuring liver stiffness directly by Shaw hardmeter. Therefore, this prospective, multicenter clinical study intends to modify and perfect the preoperative cirrhotic severity scoring (TJ-CSS) and direct measurement of liver stiffness (DMS) grade established in the early period, so as to build a set of clinical standards for surgical liver cirrhosis classification, which can be used to guide the surgical treatment of HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular Carcinoma | Patients with hepatocellular carcinoma undergo open hepatectomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS) | The calculation of TJ-CSS will be based on four clinical parameters (esophageal varices severity, portal vein diameter, spleen thickness and platelet account). | within 10 days prior to hepatectomy |
| Liver stiffness measurement | Liver stiffness will be measured by LX-C Shaw hardmeter. | during operation |
| Pathological stage of liver cirrhosis | Liver cirrhosis will be sub-staged according to Laennec staging system | Within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of cirrhotic severity and extent of hepatectomy on the incidence of post-hepatectomy liver failure (PHLF) | PHLF was diagnosed by the "50-50 criteria" characterized by the combination of a prothrombin time index of <50% and serum total bilirubin level of >50 mmol/L on postoperative day 5 | postoperative day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who undergo open liver resection with curative intent for HCC and meet the eligibility criteria from 6 hospitals in China (Wuhan Tongji Hospital, Wuhan Union Hospital, Wuhan Zhongnan hospital, Hubei Cancer Hospital, Shiyan Taihe Hospital, Xiangyang Central Hospital) will be selected.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyong Huang | Contact | +86 27 83665392 | zyhuang126@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Chen | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38617471 | Derived | Liang BY, Zhang EL, Li J, Long X, Wang WQ, Zhang BX, Zhang ZW, Chen YF, Zhang WG, Mei B, Xiao ZY, Gu J, Zhang ZY, Xiang S, Dong HH, Zhang L, Zhu P, Cheng Q, Chen L, Zhang ZG, Zhang BH, Dong W, Liao XF, Yin T, Wu DD, Jiang B, Yuan YF, Zhang ZL, Chen YB, Li KY, Lau WY, Chen XP, Huang ZY. A combined pre- and intra-operative nomogram in evaluation of degrees of liver cirrhosis predicts post-hepatectomy liver failure: a multicenter prospective study. Hepatobiliary Surg Nutr. 2024 Apr 3;13(2):198-213. doi: 10.21037/hbsn-22-410. Epub 2023 Mar 15. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Surgically resected non-tumor liver tissues will be retained
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |