The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Survival without pericardial effusion at 2 months
Successful extubation of pericardial drainage tube
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
symptom palliation
complication
long-term (> 6 months) effect on cardiac function
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