Status:
UNKNOWN
Multi-center Clinical Study on the Decision Tree of Precision Hepatectomy in China Precision Hepatectomy Decision Tree
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Collaborating Sponsors:
West China Hospital
Second Affiliated Hospital, Sun Yat-Sen University
Conditions:
Primary Liver Cancer
Metastatic Liver Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
Liver failure (PHLF) after hepatectomy is a relatively serious postoperative complication. Previous studies have shown that liver reserve function is related to PHLF. The "Chinese expert consensus dec...
Detailed Description
Hepatectomy is an effective treatment for primary liver cancer, with excellent efficacy and controllable safety . The incidence of non fatal complications after Hepatectomy is as high as 45%, ranging ...
Eligibility Criteria
Inclusion
- Age 18-70 years old, gender unlimited;
- 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;
- Child-Pugh liver function rating A/B;
- ECOG PS score 0-2 points;
- 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);
- If the patient is HBV antigen positive and the HBV DNA is less than 1.0E+04 IU/ml, routine antiviral treatment is required;
- Patients with portal hypertension can be included, and the severity can refer to endoscopic esophageal varices or splenomegaly and hypersplenism;
- 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;
- The patient's expected survival period is more than 3 months;
- No pregnancy or pregnancy plan;
- No other contraindications for operation;
- Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up.
Exclusion
- Extrahepatic metastasis of primary liver cancer;
- Diffuse liver cancer;
- Suffering from vascular liver diseases such as sinus obstruction syndrome, Budd-Chiari syndrome and congenital vascular malformation;
- Patients with obstructive jaundice or cholestasis;
- Preoperative bilirubin\>50umol/L (2.9 mg/dL);
- Pregnant women;
- Have a history of mental illness or abuse of psychotropic substances;
- Joint HIV infected patients;
- With other malignant tumors;
- Floating population and other patients with poor compliance;
- Clinical trials involving other experimental drugs or devices within four weeks;
- The researcher believes that it is not suitable for enrollment.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT05986383
Start Date
August 1 2023
End Date
March 1 2024
Last Update
August 14 2023
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