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

NCT ID: NCT06245798

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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liver resection

No interventions assigned to this group

transarterial chemoembolisation

transarterial chemoembolisation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tangdu hospital

Xi'an, Shaanxi, China

Site Status

Xijing hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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Tangdu Hospital

Identifier Type: -

Identifier Source: org_study_id

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