Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax
|ClinicalTrials.gov Identifier: NCT00520221|
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
|Condition or disease|
Primary spontaneous pneumothorax (PSP) most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode. The high recurrence rate stimulated the development of many different therapeutic approaches, ranging from conservative treatment such as observation to more invasive therapies such as surgery, and optimal treatment of patients presenting with a first episode of PSP remains controversial. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as the first line treatment for all PSP requiring intervention because this treatment provided the advantage of reduced hospital admission rate and reduced length of hospital stay when compared with chest tube drainage. However, the recurrence rate of this procedure was around 30%, making it inappropriate as a standard of care.
Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Previously, chemical pleurodesis had usually been administrated through chest tube or thoracoscopy. Administration of sclerosing agents through intravenous needle catheter or pigtail catheter after simple aspiration had never been reported and the safety and efficacy remained unknown.
Because the recurrence rate after simple aspiration remains high, we began to instill minocycline into the pleural cavity through the pigtail or intravenous needle catheter since December 2005 to determine if this adjuvant is effective in reducing the rate of recurrence. In the present study, we report our experience of minocycline pleurodesis in treating first episode of PSP after successful aspiration of pneumothorax. The effects of this adjuvant therapy were evaluated by comparing the outcomes of the patients who underwent simple aspiration alone with those who underwent additional minocycline pleurodesis.
|Study Type :||Observational|
|Actual Enrollment :||64 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Intrapleural Minocycline Following Simple Aspiration for Initial Treatment of Primary Spontaneous Pneumothorax: a Retrospective Study|
|Study Start Date :||January 2004|
|Study Completion Date :||July 2007|
U.S. FDA Resources
Treatment Comparison: 2
Minocycline group: 300 mg of minocycline hydrochloride was instilled into the pleural space through the catheter.
Control group consisted of 33 patients who had successful simple aspiration alone between January 2004 and December 2005.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520221
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Yung-Chie Lee, MD, PhD||Department of Surgery, National Taiwan University Hospital, Taiwan|
|Study Director:||Jin-Shing Chen, MD, PhD||Department of Surgery, National Taiwan University Hospital, Taiwan|