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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial E

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 Summary:

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.


Sponsor: Japan Clinical Oncology Group

Current Primary Outcome: Survival without pericardial effusion at 2 months

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Japan Clinical Oncology Group

Dates:
Date Received: August 19, 2005
Date Started: August 1999
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016