Multi-center Clinical Study on the Decision Tree of Precision Hepatectomy in China Precision Hepatectomy Decision Tree

Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Aug 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to liver surgery called precision hepatectomy, which aims to help patients with different types of liver conditions, including primary liver cancer, metastatic liver cancer, benign liver tumors, and certain infections. The goal is to find the safest and most effective way to remove liver tumors while considering each patient’s liver function, which is important for recovery. Although earlier studies showed that this method can be helpful, this trial will gather more evidence by observing patients who meet specific criteria before their surgery.

To be eligible for the trial, participants need to be between 18 and 70 years old and have certain types of liver conditions that can be treated surgically. They should also have a specific range of liver function and overall health status. Participants will be monitored closely throughout the study, and they will need to provide informed consent to join. It’s important to note that individuals with certain severe liver diseases, other cancers, or significant health issues may not be able to participate. This trial will help improve surgical options and outcomes for liver cancer patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-70 years old, gender unlimited;
• • 2. Primary liver cancer patients who strictly comply with the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2019 version) or who have been confirmed by histopathological or cytological examination, or patients with benign liver neoplasms, or metastatic liver cancer;
• • 3. Child-Pugh liver function rating A/B;
• • 4. ECOG PS score 0-2 points;
• • 5. The liver tumor can be resected (the remaining liver vessel structure is complete, the liver volume is sufficient, and conforms to the decision system of safe hepatectomy);
• • 6. If the patient is HBV antigen positive and the HBV DNA is less than 1.0E+04 IU/ml, routine antiviral treatment is required;
• • 7. Patients with portal hypertension can be included, and the severity can refer to endoscopic esophageal varices or splenomegaly and hypersplenism;
• • 8. Use up to 3 antihypertensive drugs to fully control blood pressure (BP), which is defined as BP\<=150/90 mm Hg (mmHg) during screening, and there is no change in antihypertensive treatment within 1 week before the first cycle/day;
• • 9. The patient's expected survival period is more than 3 months;
• • 10. No pregnancy or pregnancy plan;
• • 11. No other contraindications for operation;
• • 12. Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up.
• Exclusion Criteria:
• • 1. Extrahepatic metastasis of primary liver cancer;
• • 2. Diffuse liver cancer;
• • 3. Suffering from vascular liver diseases such as sinus obstruction syndrome, Budd-Chiari syndrome and congenital vascular malformation;
• • 4. Patients with obstructive jaundice or cholestasis;
• • 5. Preoperative bilirubin\>50umol/L (2.9 mg/dL);
• • 6. Pregnant women;
• • 7. Have a history of mental illness or abuse of psychotropic substances;
• • 8. Joint HIV infected patients;
• • 9. With other malignant tumors;
• • 10. Floating population and other patients with poor compliance;
• • 11. Clinical trials involving other experimental drugs or devices within four weeks;
• • 12. The researcher believes that it is not suitable for enrollment.