Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Heart and Blood Diseases

Lung Neoplasms

Pericardial Effusion

Heart Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Infective Agents

Bleomycin

Sclerosing Solutions

Anti-Bacterial Agents

Antibiotics, Antitubercular

Procedure/Surgery: Observation alone after pericardial drainage

Drug: Pericardial instillation of bleomycin after drainage

Observation alone after pericardial drainage

Pericardial instillation of bleomycin after drainage

Tomohide Tamura, MD

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.

Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion

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)

Ministry of Health, Labour and Welfare, Japan

Japan Clinical Oncology Group

Tomohide Tamura , MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion	NCT00132613	Malignant Peric...	Observation alo... Pericardial ins...	- 75 Years	Japan Clinical Oncology Group
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion	NCT00132613	Malignant Peric...	Observation alo... Pericardial ins...	- 75 Years	Japan Clinical Oncology Group

Spots Global Cancer Trial Database for intrapericardial instillation