Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076631
• Other study ID #: CXPJJH11900009
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Tongji Hospital
• Contact: Zhiyong Huang
• Phone: +86 27 83665392
• Email: zyhuang126[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female, 18 to 75 years of age, inclusive.

2. Patients who are clinically diagnosed as hepatocellular carcinoma and confirmed by postoperative pathology.

3. The liver function grade was Child-Pugh class A or class B, which can be restored to Child-Pugh class A within a short period of medical treatment.

4. Patients who undergo open surgery.

5. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.

6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with tumors that oppress the main portal vein or main portal vein thrombus.

2. Patients that are accompanied with cavernous degeneration of portal vein.

3. Patients with hypersplenism caused by diseases of the blood system.

4. Patients suffer from serious acute and chronic diseases.

5. Patients with severe infectious diseases.

6. Patients with HIV-infectious or other AIDS-related disease.

7. Patients are drug abusers or have any psychological or mental conditions that potentially lead to poor study compliance.

8. Patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Liver stiffness measurement	Liver stiffness will be measured by LX-C Shaw hardmeter.	during operation
Primary	Pathological stage of liver cirrhosis	Liver cirrhosis will be sub-staged according to Laennec staging system	Within 30 days after surgery
Secondary	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