Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

NCT ID: NCT00839553

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-04-30

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. 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.

Conditions

Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Intrapleural Minocycline application

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Department of Health

AMBIG

Sponsor Role: collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Principal Investigators

YC Lee, PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

Far Eastern Memorial Hospital

Banqiao District, Taipei, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kuang-Chau Tsai, Master

Role: CONTACT

hikali@mail.femh.org.tw

886-2-89667000 ext. 1125

Facility Contacts

Kuang-Chau Tsai, Master

Role: primary

hikali@mail.femh.org.tw

886-2-89667000 ext. 1125

Other Identifiers

95042

Identifier Type: -

Identifier Source: org_study_id