ISP-TACE Versus TACE for HCC With PVTT

NCT ID: NCT03108248

Last Updated: 2017-04-11

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

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2017-03-25

Brief Summary

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For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.

Detailed Description

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Conditions

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HCC Portal Vein Tumor Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ISP-TACE group

During the study period, a total of 44 patients with HCC with PVTT underwent the irradiation stent placement and TACE were included in the ISP-TACE group.

ethiodized oil; doxorubicin;Gelfoam;

Intervention Type DRUG

Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.

TACE group

During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group.

ethiodized oil; doxorubicin;Gelfoam;

Intervention Type DRUG

Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.

stent; idoine-125

Intervention Type DEVICE

In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.

Interventions

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ethiodized oil; doxorubicin;Gelfoam;

Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.

Intervention Type DRUG

stent; idoine-125

In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.

Exclusion Criteria

* (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao-jun Teng

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital,Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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ZhongdaHP

Identifier Type: -

Identifier Source: org_study_id

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