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

UMIN ID: C000000050

Registered date:07/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant vena cava stenosis.
• Date of first enrollment: 2005/10/01
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Metallic stents are placed in malignant vena cava stenosis using angiography technique.

Outcome(s)

• Primary Outcome: Improvement of clinical symptoms
• Secondary Outcome: Adverse events, improvement of findings on venography, techinical success rate.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group(JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare