Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132613
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-08-19
Brief Title:
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
Sponsor:
Japan Clinical Oncology Group
Organization:
Japan Clinical Oncology Group
Study Overview
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 Effusion Associated With Lung Cancer JCOG9811
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Comparison Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C000000030 | None | None | None |