Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
- Conditions
- Malignant Pericardial Effusion
- Interventions
- Drug: Pericardial instillation of bleomycin after drainageProcedure: Observation alone after pericardial drainage
- Registration Number
- NCT00132613
- Lead Sponsor
- Japan Clinical Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Pericardial instillation of bleomycin after drainage Drug: Pericardial instillation of bleomycin after drainage 1 Observation alone after pericardial drainage Procedure/Surgery: Observation alone after pericardial drainage
- Primary Outcome Measures
Name Time Method Survival without pericardial effusion at 2 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (31)
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Aichi Cancer Center,Aichi Hospital
🇯🇵Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital
🇯🇵Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Gifu Municipal Hospital
🇯🇵Gifu,Kashima-cho,7-1, Gifu, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
National Nishigunma Hospital
🇯🇵Shibukawa,Kanai,2854, Gunma, Japan
National Hospital Organization, Dohoku National Hospital
🇯🇵Asahikawa,Hanasaki,7-4048, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Scroll for more (21 remaining)Aichi Cancer Center Hospital🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan