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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418392
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 4, 2007
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

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 to test if it can reduce the rate of recurrence.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: Simple aspiration with minocycline pleurodesis Procedure: simple aspiration Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial
Study Start Date : November 2006
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Safety profile of minocycline pleurodesis [ Time Frame: 12 months after treatment ]
  2. 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 ]
  3. Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test [ Time Frame: 12 months after treatment ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418392

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

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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
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Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital Identifier: NCT00418392    
Other Study ID Numbers: 950510
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: November 2012
Keywords provided by National Taiwan University Hospital:
pneumothorax, aspiration, minocycline, pleurodesis
Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents