Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

NCT ID: NCT06245785

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

Brief Summary

Hepatic dysfunction limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. Established practice guidelines for patients with HCC and impaired liver function are lacking. The treatment allocation in these populations is heterogeneous and remains controversial. This study compared the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in patients with HCC and impaired liver function.

Conditions

Hepatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

liver resection

No interventions assigned to this group

transarterial chemoembolisation

transarterial chemoembolisation

Intervention Type: PROCEDURE

Before TACE, hepatic arteriography was performed to evaluate the vascular anatomy and tumour vascularity. During TACE, a vascular catheter was selectively inserted into the tumour-feeding artery with an injection containing a mixture of doxorubicin (10-50 mg) and lipiodol (2-20 mL), followed by embolisation using gelatin sponge particles. TACE was repeated when residual viable tumours were confirmed or new lesions developed in patients with adequate liver function. Laboratory assessments were performed every four to six weeks. Radiological evaluation using contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) was recommended during weeks 4 and 8 after treatment and every 8 weeks thereafter. However, in clinical practice, the intensity of follow-up depends on an individual's baseline characteristics and response to the last treatment.

Interventions

transarterial chemoembolisation

Before TACE, hepatic arteriography was performed to evaluate the vascular anatomy and tumour vascularity. During TACE, a vascular catheter was selectively inserted into the tumour-feeding artery with an injection containing a mixture of doxorubicin (10-50 mg) and lipiodol (2-20 mL), followed by embolisation using gelatin sponge particles. TACE was repeated when residual viable tumours were confirmed or new lesions developed in patients with adequate liver function. Laboratory assessments were performed every four to six weeks. Radiological evaluation using contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) was recommended during weeks 4 and 8 after treatment and every 8 weeks thereafter. However, in clinical practice, the intensity of follow-up depends on an individual's baseline characteristics and response to the last treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients with HCC who received conventional LR or TACE

Exclusion Criteria

• （1） presence of portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion
• （2） extrahepatic spread (EHS)
• （3） albumin-bilirubin grade 1 or 3
• （4） Eastern Cooperative Oncology Group Performance Status (ECOG-PS) >1
• （5） tumour number >3
• （6） other tumours or severe cardiac, cerebral, and renal insufficiency
• （7）ascites, hepatic encephalopathy, and jaundice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhao s jie

Role: PRINCIPAL_INVESTIGATOR

Teachers and students

Locations

Tangdu hospital

Xi'an, Shaanxi, China

Xijing hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

liu lei

Identifier Type: -

Identifier Source: org_study_id