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A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Start Date
August 1, 2019
Primary Completion Date
November 1, 2020
Completion Date
December 1, 2020
Last Updated
October 12, 2020
1,000
ESTIMATED participants
Lead Sponsor
Chen Xiaoping
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06811116