Clinical trial NCT04076631: Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma
Official title: A Prospective, Multicenter Clinical Study On Surgical Stages of Liver Cirrhosis In Patients With HBV-Related Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative assessment of cirrhotic severity by cirrhotic severity scoring (TJ-CSS)
timeFrame: within 10 days prior to hepatectomy
measure: Liver stiffness measurement
timeFrame: during operation
measure: Pathological stage of liver cirrhosis
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: The effect of cirrhotic severity and extent of hepatectomy on the incidence of post-hepatectomy liver failure (PHLF)
timeFrame: postoperative day 5
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen
role: PRINCIPAL_INVESTIGATOR
References: