Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome (JIVROSG-0807)

Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome (JIVROSG-0807) - Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003579

Enrollment

Registered

2010-05-08

Start date

2009-11-01

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 syndrome

Interventions

Placement of vena cava stent (VCS). Treatments other than VCS.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Vena cava syndrome interfering the daily life. 2. Palliative prognosis index less than 6. 3. Written informed consent from the patients. 4. Twice measurement of symptom score and health-related quality-of-life.

Exclusion criteria

Exclusion criteria: 1. Possible rapid reduction in symptom with chemotherapy or radiotherapy. 2. Not significant symptom from stenosis of vena cava. 3. Platelet count <50,000/mm3 or serum creatinine >=2.0mg/dL or total bilirubin >=3.0mg/dL. 4. Massive floating thrombus in periphery to stenosis. 5. (1) Significant cardiac disease, (2) deformity of the cardiac contour by tumor, (3) impaired cardiac function from cardiac tamponade or pulmonary thromboembolism evaluated with EKG and cardiac echo. 6. Symptomatic stenoses both in superior and inferior vena cava. 7. Candidate to bypass surgery for stenosis of vena cava. 8. Active infection. 9. Presence of acute bleeding conditions. 10. Difficulties in the evaluation of symptomatic score or quality-of-life. 11. Pregnancy. 12. Contraindication decided by the participating physician.

Design outcomes

Primary

Measure	Time frame
Improvement of the symptoms from malignant vena cava syndrome.	—

Secondary

Measure	Time frame
Improvement of health-related QOL, toxicity profile, and survival time.	—

Countries

Japan

Contacts

Public ContactYasuaki Arai

National Cancer Center Hospital Division of Diagnostic Radiology

arai-y3111@mvh.biglobe.ne.jp03-3542-2511

Outcome results

None listed

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