A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)

UMIN ID: C000000041

Registered date:06/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant vertebral bone tumor.
• Date of first enrollment: 2003/02/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the vertebral body involved by malignant tumor and cement is injected.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Pain evaluated by Visual Analogue Scale (VAS).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Bleeding time more than 5 minutes. 2) Fever above 38 degrees Celsius. 3) Cardiac failure requiring medication. 4) Active inflammation in vertebrae 5) Severely collapsed vertebrae (less than one third of normal height). 6) No severe pain (less than 2 of VAS). 7) Unable to keep prone position for 1 hour. 8) Necessity of procedure for more than 5 contiguous vertebral bodies. 9) Necessity of single session procedure for more than 4 vertebral bodies. 10) Severe drug allergy. 11) Pregnancy.

Related Information

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