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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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00132613
Enrollment
80
Registered
2005-08-22
Start date
1999-08-31
Completion date
2006-11-30
Last updated
2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pericardial Effusion

Keywords

pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation

Brief summary

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

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.

Interventions

PROCEDUREObservation alone after pericardial drainage
DRUGPericardial instillation of bleomycin after drainage

Sponsors

Ministry of Health, Labour and Welfare, Japan
CollaboratorOTHER_GOV
Japan Clinical Oncology Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survival without pericardial effusion at 2 months

Secondary

MeasureTime frame
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
Successful extubation of pericardial drainage tube
complication
long-term (> 6 months) effect on cardiac function
symptom palliation

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026