Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

NCT06245785 | Completed

• 1 other identifier: liu lei
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• overall survival

  The overall survival rate at 5 years

  5 year

Study Arms (2)

liver resection

transarterial chemoembolisation

Procedure: transarterial chemoembolisation

Interventions

transarterial chemoembolisation 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.

transarterial chemoembolisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study data were extracted from a nationwide database of patients with HCC treated at 15 Chinese centres between January 2012 and December 2022.We included patients who were diagnosed with HCC according to the American Association for the Study of the Liver Disease/European Association for the Study of the Liver Guidelines and who received conventional LR or TACE

You may qualify if:

• patients with HCC who received conventional LR or TACE

You may not qualify if:

• （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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (2)

Tangdu hospital

Xi'an, Shaanxi, 710000, China

Location

Xijing hospital

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• zhao s jie

  Teachers and students

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)