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)
Malignant pericardial effusions (MPEs), which are commonly associated with cardiac
tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients,
MPE is one of the most unpleasant terminal events. Drainage usually results in prompt
palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial
instillation of various agents is reported to prevent the recurrence, and bleomycin is the
most commonly used drug, with fewer toxicities compared with others. There is, however, no
prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it
is far from clear whether sclerosis really benefits these patients in terminal stages.
Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus
drainage alone for MPEs caused by lung cancer.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival without pericardial effusion at 2 months
Tomohide Tamura, MD
National Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare