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A phase II study of stent therapy for malignant 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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000050
Enrollment
28
Registered
2005-08-07
Start date
2005-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant vena cava stenosis.

Interventions

Metallic stents are placed in malignant vena cava stenosis using angiography technique.

Sponsors

Japan Interventional Radiology in Oncology Study Group(JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Improvement of clinical symptoms

Secondary

MeasureTime frame
Adverse events, improvement of findings on venography, techinical success rate.

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3352-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026