Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
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.
Inclusion Criteria:

 -  Pathologically documented lung cancer

 -  Clinically stable condition after pericardial drainage for malignant pericardial
 effusion (not necessary that it be documented by cytology)

 -  Expected to live 6 weeks or longer

 -  Sufficient organ function

 -  Signed informed consent

 Exclusion Criteria:

 -  Myocardial infarction or unstable angina within 3 months

 -  Constrictive pericarditis

 -  Active pneumonitis

 -  Severe infection or disseminated intravascular coagulation (DIC)

 -  Other severe co-morbidity which could not be relieved with pericardial drainage

 -  Chemotherapy-naive small cell lung cancer