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Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

NCT00839553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-02-09

No results posted yet for this study

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

Interventions

PROCEDURE

Intrapleural Minocycline application

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Department of Health

    collaborator AMBIG

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • YC Lee, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Completion
2009-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00839553 on ClinicalTrials.gov