Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus
NCT ID: NCT02971345
Last Updated: 2020-06-11
Study Results
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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UNKNOWN
PHASE3
253 participants
INTERVENTIONAL
2017-01-31
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
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.
Stent
Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.
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.
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.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
TACE alone
Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
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.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Interventions
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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.
Stent
Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.
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.
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.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
* (3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
* (4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
* (5) Child-Pugh classification grade A or B;
* (6) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
Exclusion Criteria
* (2) Advanced liver disease (bilirubin levels \>3 mg/dL, Aspartate transaminase or Alanine aminotransferase \>5 × upper limit of normal)；
* (3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
* (4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
* (5) Renal failure,cardiac ejection fraction (\<50 %) or end-stage disease;
* (6) Patients who were not capable of cooperation during the procedure.
18 Years
70 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Lishui Country People's Hospital
OTHER
Zhejiang University
OTHER
Changhai Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
The Second People's Hospital of Yibin
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
LanZhou University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
First Hospital of China Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
Fujian Provincial Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
ZhuHai Hospital
OTHER
Zhongshan Hospital Xiamen University
OTHER
Yancheng Third People's Hospital
UNKNOWN
Changzhou Wujin People's Hospital
UNKNOWN
Tengzhou Central People's Hospital
OTHER_GOV
Harbin Medical University
OTHER
Hunan Cancer Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhiping Yan, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Jianjun Luo, MD
Role: STUDY_DIRECTOR
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Locations
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Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Luo J, Yan Z, Liu Q, Qu X, Wang J. Endovascular placement of iodine-125 seed strand and stent combined with chemoembolization for treatment of hepatocellular carcinoma with tumor thrombus in main portal vein. J Vasc Interv Radiol. 2011 Apr;22(4):479-89. doi: 10.1016/j.jvir.2010.11.029.
Luo JJ, Zhang ZH, Liu QX, Zhang W, Wang JH, Yan ZP. Endovascular brachytherapy combined with stent placement and TACE for treatment of HCC with main portal vein tumor thrombus. Hepatol Int. 2016 Jan;10(1):185-95. doi: 10.1007/s12072-015-9663-8. Epub 2015 Sep 4.
Yang M, Fang Z, Yan Z, Luo J, Liu L, Zhang W, Wu L, Ma J, Yang Q, Liu Q. Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial. J Cancer Res Clin Oncol. 2014 Feb;140(2):211-9. doi: 10.1007/s00432-013-1568-0. Epub 2013 Dec 28.
Other Identifiers
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ZS-IR-2016
Identifier Type: -
Identifier Source: org_study_id
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