Clinical Trial: Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial
Brief Summary:
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.
Detailed Summary:
Background:
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode (3). Optimal treatment of patients presenting with a first episode of primary spontaneous pneumothorax remains unknown. In the recently published British Thoracic Society (BTS) guidelines (4), 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 26-30% (5), 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 (6, 7). Light et al. has shown that intrapleural tetracycline is effective in reducing the rate of ipsilateral recurrence for patients with spontaneous pneumothorax (7). However, the recently published guidelines recommended that chemical pleurodesis should only be attempted if the patient is either unwilling or unable to undergo surgery because the rates of recurrence of pneumothoraces after surgical intervention either by thoracotomy or VATS, with or without surgical pleurodesis, is far less than after chemical pleurodesis (4, 8). As a result, chemical pleurodesis has rarely been used in primary spontaneous pneumothorax, and the effect of additional chemical pleurodesis after simple aspiration in preventing recurrence of pneumothoraces has never been evaluated.
Tetracycline, which was the most commonly used irritant, is no longer available. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits (9). In th
Sponsor: National Taiwan University Hospital
Current Primary Outcome: 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 ]
Original Primary Outcome: to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax.
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Safety profile of minocycline pleurodesis
- Early results, including immediate success rates, one-week success rates, complication rates, rates of hospitalization, duration of hospitalization, and the degrees of chest pain.
- Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test
Information By: National Taiwan University Hospital
Dates:
Date Received: December 31, 2006
Date Started: November 2006
Date Completion: December 2012
Last Updated: December 13, 2012
Last Verified: November 2012
