Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

Pneumothorax Clinical Trial

Official title:

Intrapleural Minocycline After Manual Aspiration for the Prevention of Primary Spontaneous Pneumothorax. A Phase III Multicenter Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00839553
• Other study ID #: 95042
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2009
• Last updated: February 6, 2009
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: Far Eastern Memorial Hospital
• Contact: Kuang-Chau Tsai, Master
• Phone: 886-2-89667000
• Email: hikali[@]mail.femh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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. The primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. The secondary goals are to evaluate the safety profile, short-term results, and long-term effects of minocycline pleurodesis after simple aspiration. The sites of study include National Taiwan University Hospital and Far Eastern Memorial Hospital. A total of 300 patients (150 patients in each arm) will be included for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 15-50years old

2. primary pneumothorax first attack

3. viceral pleura to chest wall more then 2 cm on CXR

Exclusion Criteria:

1. the lungs unable to expad fully after aspiration

2. continuous leakage of air through chest tubes

3. status complicated with hemothorax

4. status post previous chest surgery or pleurodesis

5. patient unwilling to accept the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Procedure:
• Intrapleural Minocycline application

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Pan-Chiao	Taipei county

Sponsors (3)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Department of Health, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate