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NCT06245798 Clinical Trial

Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension

Hepatic Carcinoma Clinical Trial

Official title:
Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension: A Chinese Multicentre Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06245798
Other study ID # Tangdu Hospital
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 1, 2023

Study information
Verified date January 2024
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinically significant portal hypertension limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. HCC patients with CPSH are heterogeneous and treatment allocation remains controversial. The aim of this study was to compare the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in these populations.

Recruitment information / eligibility
Status Completed
Enrollment 3000
Est. completion date December 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - HCC patients treated conventional liver resection or transarterial chemoembolisation Exclusion Criteria: - (1) presence of types III/IV portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion; (2) presence of extrahepatic spread (EHS); (3) underwent previous treatments; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) >1; (5) diffuse tumor nodules; (6) combined with other tumours or severe cardiac, cerebral, and renal insufficiency; (7) non-Clinically significant portal hypertension(CSPH), and (8) absence of baseline information

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transarterial chemoembolisation
During transarterial chemoembolisation(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

Locations
Country Name City State
China Tangdu hospital Xian Shaanxi
China Xijing hospital Xian Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival rate overall survival rate 5 year
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