Unique ID issued by UMIN | C000000050 |
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Receipt number | R000000095 |
Scientific Title | A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402) |
Date of disclosure of the study information | 2005/08/07 |
Last modified on | 2010/02/11 15:11:01 |
A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)
Stent therapy for vena cava syndrome (JIVROSG-0402)
A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)
Stent therapy for vena cava syndrome (JIVROSG-0402)
Japan |
Malignant vena cava stenosis.
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Endocrinology and Metabolism | Hematology and clinical oncology | Nephrology |
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Vascular surgery |
Chest surgery | Endocrine surgery | Breast surgery |
Obstetrics and Gynecology | Dermatology | Orthopedics |
Urology | Radiology |
Malignancy
NO
To evaluate the efficacy of stent therapy for malignant vena cava syndrome.
Efficacy
Confirmatory
Explanatory
Phase II
Improvement of clinical symptoms
Adverse events, improvement of findings on venography, techinical success rate.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Metallic stents are placed in malignant vena cava stenosis using angiography technique.
Not applicable |
Not applicable |
Male and Female
1) Symptomatic malignant vana cava stenosis in superior vena cava or inferior vena cava confirmed by contrast enhanced CT.
2) Uncontrolled symptom by medical treatment.
3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
5) Expected survival more than 4 weeks.
6) Written informed consent.
1) Potential benefit for symptom relief by chemotherapy, radiotherapy, or surgery.
2) Intraluminal tumor thrombus resulting in stenosis of vena cava.
3) Floating thrombus distal to stenosis.
4) Stenoses both in superior and inferior vena cava.
5) Central venous pressure higher than 8cm H2O.
6) Deformity of cardiac cavity, cardiac tamponade or severe functional disorder oberved by electrocardiogram and ultrasound examination.
7) Stenosis existinf both in SVC and IVC.
8) Active inflammatory disease.
9) Acute active bleeding.
10) Pregnancy.
28
1st name | |
Middle name | |
Last name | Yoshito Takeuchi |
Kyoto 1st Redcross Hospital
Department of Radiology
15-749, Honmachi, Higashiyama-ku, Kyoto, 605-0981, Japan
075-561-1121
1st name | |
Middle name | |
Last name | Yasuaki Arai |
JIVROSG, Coordinating Office
Division of Diagnostic Radiology, National Cancer Center Hospital
5-1-1, Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3352-2511
http://jivrosg.umin.jp/
jivrosgoffice@ml.res.ncc.go.jp
Japan Interventional Radiology in Oncology Study Group(JIVROSG)
Ministry of Health, Labour and Welfare
Japan
NO
2005 | Year | 08 | Month | 07 | Day |
http://jivrosg.umin.jp/
Unpublished
http://jivrosg.umin.jp/
Patients: age (median) 60.5y (29-91), male 16/female 12, SVC 16/ IVC 12
Technical success: 100%
Angiographic success: 96.4%
Clinical success: 71.4% (95% CI: 54.7-88.1%)
Time-to-improvement (median): 1 day
Adverse events (>=G3): 7.14
Completed
2005 | Year | 06 | Month | 13 | Day |
2005 | Year | 10 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 06 | Month | 01 | Day |
2005 | Year | 08 | Month | 07 | Day |
2010 | Year | 02 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000095
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