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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 range18 Years – 70 Years

SexALL

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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;
✓. 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

What they're measuring

Postoperative liver failure rate (50-50 criteria)

Timeframe: postoperative day 3 and postoperative day 5

Trial details

NCT IDNCT05986383

SponsorBeijing Tsinghua Chang Gung Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03

Contact for this trial

Jiahong Dong, academician

18810108028 dongjiahong@mail.tsinghua.edu.cn

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