Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax
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|ClinicalTrials.gov Identifier: NCT00418392|
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : January 4, 2007
Last Update Posted : December 17, 2012
The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.
Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.
|Condition or disease||Intervention/treatment||Phase|
|Pneumothorax||Procedure: Simple aspiration with minocycline pleurodesis Procedure: simple aspiration||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||December 2012|
U.S. FDA Resources
Experimental: Minocycline group
After successful simple aspiration, minocycline pleurodesis will be performed.
Procedure: Simple aspiration with minocycline pleurodesis
Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration
Placebo Comparator: Control group
After successful simple aspiration, nothing will be performed.
Procedure: simple aspiration
Simple aspiration for primary spontaneous pneumothorax by pigtail catheter
- to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax. [ Time Frame: 12 months after treatment ]
- Safety profile of minocycline pleurodesis [ Time Frame: 12 months after treatment ]
- Early results, including immediate success rates, one-week success rates, complication rates, rates of hospitalization, duration of hospitalization, and the degrees of chest pain. [ Time Frame: 7 days after treatment ]
- Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test [ Time Frame: 12 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418392
|Contact: Jin-Shing Chen, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178 email@example.com|
|Principal Investigator: Yung-Chie Lee, MD, PhD|
|Sub-Investigator: Jin-Shing Chen, MD, PhD|
|Sub-Investigator: Kuang-Chau Tsai, MD|
|Sub-Investigator: Wen-Jone Chen, MD, PhD|
|Study Chair:||Yung-Chie Lee, MD, PhD||National Taiwan University Hospital|