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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Malignant Pericardial Effusion

Intervention / Treatment
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* Procedure: Observation alone after pericardial drainage
* Drug: Pericardial instillation of bleomycin after drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: Observation alone after pericardial drainage | Procedure: Observation alone after pericardial drainage<br> <br> |
| Experimental: 2<br>Drug: Pericardial instillation of bleomycin after drainage | Drug: Pericardial instillation of bleomycin after drainage<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without pericardial effusion at 2 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation