Clinical trial · Observational
Multi-center Clinical Study on the Decision Tree of Precision Hepatectomy in China Precision Hepatectomy Decision Tree
A Prospective, Multi-center Clinical Study on the Safety and Effectiveness of Chinese Precision Hepatectomy Decision Tree
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Liver Neoplasms | Benign Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hepatic Echinococcosis | — | UNRESOLVED | — |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (6)
- label
- Guoup 1
- description
- Liver function is Child Pugh A:If ICG-R15\<10%, the standardized residual functional liver volume ratio (RRS) ≥ 40%
- label
- Guoup 2
- description
- Liver function is Child Pugh A:If ICG-R15 is 10% - 20%, RRS ≥ 60%
- label
- Guoup 3
- description
- Liver function is Child Pugh A:If ICG-R15 is 21% - 30%, RRS ≥ 80%
- label
- Guoup 4
- description
- Liver function is Child Pugh A:If ICG-R15 is 31%\~40%, only minimal hepatectomy with hepatectomy rate less than 5% can be performed
- label
- Guoup 5
- description
- Liver function is Child Pugh A:If ICG-R15\>40%, only tumor resection is feasible
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available