Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax
Information source: Far Eastern Memorial Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumothorax
Intervention: Intrapleural Minocycline application (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Far Eastern Memorial Hospital Official(s) and/or principal investigator(s):
YC Lee, PhD, Study Chair, Affiliation: National Taiwan University Hospital
Overall contact:
Kuang-Chau Tsai, Master, Phone: 886-2-89667000, Ext: 1125, Email: hikali@mail.femh.org.tw
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.
Clinical Details
Official title: Intrapleural Minocycline After Manual Aspiration for the Prevention of Primary Spontaneous Pneumothorax. A Phase III Multicenter Prospective Randomized Controlled Trial
Study design: Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Recurrence rate
Eligibility
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Kuang-Chau Tsai, Master, Phone: 886-2-89667000, Ext: 1125, Email: hikali@mail.femh.org.tw
Far Eastern Memorial Hospital, Pan-Chiao, Taipei county, Taiwan; Recruiting
Kuang-Chau Tsai, Master, Phone: 886-2-89667000, Ext: 1125, Email: hikali@mail.femh.org.tw
Additional Information
Starting date: April 2007
Ending date: April 2009
Last updated: February 6, 2009
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