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Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

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ClinicalTrials.gov Identifier: NCT00270751
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2005
Last Update Posted : August 7, 2006
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Study Description
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Brief Summary:
Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: 1 apical pleurectomy Procedure: 2 pleural abrasion + minocycline pleurodesis Phase 2 Phase 3

Detailed Description:
Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Pleural Abrasion Plus Minocycline Pleurodesis Versus Apical Pleurectomy After Thoracoscopic Bullectomy for High Recurrent Risk Patients With Primary Spontaneous Pneumothorax: A Prospective Randomized Trial.
Study Start Date : April 2005
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate of pneumothorax after thoracoscopic operation.

Secondary Outcome Measures :
  1. The short-term results (Pain level, chest tube duration, hospital stay, etc)
  2. Complication rate
  3. Long-term results: residual pain
  4. Long-term pulmonary function test

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation

Exclusion Criteria:

  • With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00270751


Contacts
Contact: Yung-Chie Lee, MD, PhD 886-2-23123456 ext 5070 wuj@ha.mc.ntu.edu.tw
Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 5178 cjs@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD    886-2-23123456 ext 5178    cjs@ha.mc.ntu.edu.tw   
Principal Investigator: Yung-Chie Lee, MD, PhD         
Sub-Investigator: Jin-Shing Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Yung-Chie Lee, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
Study Director: Jin-Shing Chen, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00270751     History of Changes
Other Study ID Numbers: 31MD02
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: August 7, 2006
Last Verified: August 2006

Keywords provided by National Taiwan University Hospital:
Video-Assisted Thoracoscopic Surgery
Spontaneous pneumothorax
Pleurectomy
Pleural abrasion
Minocycline

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
 Minocycline
Anti-Bacterial Agents
Anti-Infective Agents