Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma

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).

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Hepatocellular Carcinoma

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Zhiyong Huang; Phone Number: +86 27 83665392; Email: zyhuang126@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hepatocellular Carcinoma; Patients with hepatocellular carcinoma undergo open hepatectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chen Xiaoping

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Fibrosis; Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis
• Other Study ID Numbers: CXPJJH11900009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No