ISP-TACE Versus TACE for HCC With PVTT

NCT03108248 | Completed

• 1 other identifier: ZhongdaHP
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC; Portal Vein Tumor Thrombosis

Keywords

transarterial chemoembolization; stent; irradiation; survival; decompensation; tumor response

Outcome Measures

Primary Outcomes (1)

• survival

  The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up

  0-6 years

Study Arms (2)

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.

Drug: ethiodized oil; doxorubicin;Gelfoam;

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.

Drug: ethiodized oil; doxorubicin;Gelfoam;; Device: stent; idoine-125

Interventions

ethiodized oil; doxorubicin;Gelfoam; 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.

ISP-TACE group; TACE group

stent; idoine-125 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.

TACE group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between January 2011 and December 2016, patients with HCC and PVTT underwent TACE combined with irradiation stent placement or TACE monotherapy as an initial treatment at the authors' center were retrospectively reviewed.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

Ethiodized Oil; Stents

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 11, 2017
• Study Start: January 1, 2011
• Primary Completion: December 12, 2016
• Study Completion: March 25, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

CN (1)