NIPH Clinical Trials Search

UMIN ID: C000000050

Registered date:07/08/2005

A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant vena cava stenosis.
Date of first enrollment2005/10/01
Target sample size28
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Metallic stents are placed in malignant vena cava stenosis using angiography technique.


Primary OutcomeImprovement of clinical symptoms
Secondary OutcomeAdverse events, improvement of findings on venography, techinical success rate.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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.

Related Information


public contact
Name Yasuaki Arai
Address 5-1-1, Tukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan
Telephone 03-3352-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Yoshito Takeuchi
Address 15-749, Honmachi, Higashiyama-ku, Kyoto, 605-0981, Japan Japan
Telephone 075-561-1121
Affiliation Kyoto 1st Redcross Hospital Department of Radiology