Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension
1 other identifier
observational
3,000
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedFebruary 7, 2024
January 1, 2024
3 months
January 30, 2024
January 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival rate
overall survival rate
5 year
Study Arms (2)
liver resection
transarterial chemoembolisation
Interventions
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
Eligibility Criteria
Study data were extracted from a nationwide database of HCC patients 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 liver resection or transarterial chemoembolisation
You may qualify if:
- HCC patients treated conventional liver resection or transarterial chemoembolisation
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Study Sites (2)
Tangdu hospital
Xi'an, Shaanxi, 710000, China
Xijing hospital
Xi'an, Shaanxi, 710000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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