Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus

Summary

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.

Conditions

• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombus

Interventions

PROCEDURE

Stent and Iodine-125 seed strand implantation

The patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire.

DEVICE

Stent

Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.

DEVICE

Iodine-125 seed

The number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand.

DRUG

Epirubicin

Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient.

DRUG

Ultra-fluid lipiodol

Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .

OTHER

Gelatin sponge articles

Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The Second People's Hospital of Yibin

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Zhongshan Hospital Xiamen University

  collaborator OTHER

• Yancheng Third People's Hospital

  collaborator UNKNOWN

• Changzhou Wujin People's Hospital

  collaborator UNKNOWN

• Tengzhou Central People's Hospital

  collaborator OTHER_GOV

• Harbin Medical University

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Zhiping Yan, MD · Department of Interventional Radiology, Zhongshan Hospital, Fudan University

• Jianjun Luo, MD · Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2020-10-31

Completion

2020-11-30

Countries

• China

Study Locations