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

Phase 2

• Conditions: Malignant vena cava stenosis.

• Registration Number: JPRN-C000000050
• Lead Sponsor: Japan Interventional Radiology in Oncology Study Group(JIVROSG)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-07
• Study Completion: 2008-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of clinical symptoms

Secondary Outcome Measures

Name	Time	Method
Adverse events, improvement of findings on venography, techinical success rate.