Multi-center Clinical Study on the Decision Tree of Precision Hepatectomy in China Precision Hepa… (NCT05986383) | Clinical Trial Compass
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Multi-center Clinical Study on the Decision Tree of Precision Hepatectomy in China Precision Hepatectomy Decision Tree
820 participantsStarted 2023-08
Plain-language 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 decision tree for hepatectomy" implemented recommends different surgical methods according to the liver function of patients and the standardized residual functional liver volume ratio, so as to achieve accurate hepatectomy and prolong the survival of patients. In the retrospective study, it showed the safety and effectiveness of the decision tree under the condition of extended hepatectomy indications, but it lacked prospective research to evaluate. Therefore, this study intends to evaluate the safety and effectiveness of hepatectomy under the guidance of Chinese expert consensus decision tree through prospective research.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative liver failure rate (50-50 criteria)
Timeframe: postoperative day 3 and postoperative day 5
. 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;
Exclusion criteria
. 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;