A randomized controlled trial to evaluate the efficacy of intra-pericardial instillation of a sclerosing agent after pericardial drainage in patients with malignant pericardial effusion associated with lung cancer (JCOG9811).

UMIN ID: C000000030

Registered date:28/07/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant pericardial effusion
• Date of first enrollment: 1999/08/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Observation alone after pericardial drainage
Percardial instillation of bleomycin after pericardial drainage

Outcome(s)

• Primary Outcome: Survival without pericardial effusion at 2 months
• Secondary Outcome: Succesful extubation of pericardial drainage tube, time to extubation, survival without pericardial effusion at 1,2,4,6,12months, symptom palliation, complication, long-term (>6months) effect on cardiac function.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Myocardial infarction or unstable angina within 3 months 2)constricitive pericarditis 3)active pneumonitis 4)severe infection or DIC 5)other severe co-morbidity which could not be relieved with pericardial drainage 6)chemotherapy-naive small cell lung cancer

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00132613