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Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: December 31, 2006
Last updated: December 13, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Procedure: Simple aspiration with minocycline pleurodesis
Procedure: simple aspiration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline group
After successful simple aspiration, minocycline pleurodesis will be performed.
Procedure: Simple aspiration with minocycline pleurodesis
Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration
Placebo Comparator: Control group
After successful simple aspiration, nothing will be performed.
Procedure: simple aspiration
Simple aspiration for primary spontaneous pneumothorax by pigtail catheter

  Show Detailed Description


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female.
  2. Age between 15 and 40 years old.
  3. First episode of spontaneous pneumothorax.
  4. Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration
  5. Complete or nearly complete and persistent lung expansion immediately following manual aspiration
  6. Organ Function Requirements:

    • Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L)
    • Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN
  7. Written inform consent

Exclusion Criteria:

  1. With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
  2. With hemothorax or tension pneumothorax requiring chest tube insertion or operation
  3. A history of previous pneumothorax
  4. A history of previous ipsilateral thoracic operation
  5. Allergy to tetracycline or minocycline
  6. Pregnant or lactating patients.
  7. Other serious concomitant illness or medical conditions:

    • Congestive heart failure or unstable angina pectoris.
    • History of myocardial infarction within 1 year prior to the study entry.
    • Uncontrolled hypertension or arrhythmia.
    • History of significant neurologic or psychiatric disorders, including dementia or seizure.
    • Active infection requiring i.v. antibiotics.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00418392

Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD    886-2-23123456 ext 65178   
Principal Investigator: Yung-Chie Lee, MD, PhD         
Sub-Investigator: Jin-Shing Chen, MD, PhD         
Sub-Investigator: Kuang-Chau Tsai, MD         
Sub-Investigator: Wen-Jone Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital Identifier: NCT00418392     History of Changes
Other Study ID Numbers: 950510
Study First Received: December 31, 2006
Last Updated: December 13, 2012

Keywords provided by National Taiwan University Hospital:
pneumothorax, aspiration, minocycline, pleurodesis

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 24, 2017