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

NCT05986383 | Unknown

• 1 other identifier: 21408-0-03
• Study Type: observational
• Target: 820
• Locations: 0 countries
• Sites: N/A

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 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

Primary Liver Cancer; Metastatic Liver Cancer; Benign Liver Neoplasms; Hepatic Echinococcosis

Outcome Measures

Primary Outcomes (1)

• Postoperative liver failure rate (50-50 criteria)

  The proportion of patients with Liver failure after Hepatectomy in all patients. Using the 50-50 standard.On the 5th day after surgery

  postoperative day 3 and postoperative day 5

Secondary Outcomes (18)

• Postoperative liver failure rate (ISGLS criteria)

  postoperative day 3 and postoperative day 5

• Value of indocyanine green retention test at 15 min (ICG-R15)

  postoperative day 3 and postoperative day 5

• Hepatic effective hepatic blood flow (EHBF)

  postoperative day 3 and postoperative day 5

• Postoperative remanent liver volume (mL)

  postoperative day 5

• Volume (mL) of blood loss during the operation

  the operation day

Study Arms (6)

Guoup 1

Liver function is Child Pugh A：If ICG-R15\<10%, the standardized residual functional liver volume ratio (RRS) ≥ 40%

Guoup 2

Liver function is Child Pugh A：If ICG-R15 is 10% - 20%, RRS ≥ 60%

Guoup 3

Liver function is Child Pugh A：If ICG-R15 is 21% - 30%, RRS ≥ 80%

Guoup 4

Liver function is Child Pugh A：If ICG-R15 is 31%\~40%, only minimal hepatectomy with hepatectomy rate less than 5% can be performed

Guoup 5

Liver function is Child Pugh A：If ICG-R15\>40%, only tumor resection is feasible

Guoup 6

Liver function is Child Pugh B: only tumor resection is allowed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. CNLC stage Ⅰ a\~Ⅱ b -- Ⅲ a (see the indications for hepatectomy of primary liver cancer in the 2019 edition of the diagnostic and treatment specifications for primary liver cancer); 1. CNLC stage Ⅰ a, Ⅰ b and Ⅱ a liver cancer with good liver reserve function 2. CNLC stage Ⅱ b liver cancer with tumor localized in the same segment or half of the liver on the same side. 3. The tumor is limited to the half-liver CNLC stage Ⅲ a liver cancer, and the portal vein branch tumor thrombus (Cheng's classification type I/II). 2. Patients with benign liver neoplasms; 3. Patients with metastatic liver cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• West China Hospital: collaborator
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Hospital of Jilin University: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• LanZhou University: collaborator
• Southwest Hospital, China: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shenzhen People's Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Echinococcosis, Hepatic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Echinococcosis; Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Liver Diseases, Parasitic

Central Study Contacts

Jiahong Dong, academician

CONTACT

18810108028; dongjiahong@mail.tsinghua.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08