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Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00713362
First received: July 9, 2008
Last updated: December 13, 2012
Last verified: November 2012
History of Changes
  Purpose

We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.


Condition Intervention Phase
Pneumothorax
 Procedure: Video-assisted thoracoscopic surgery
Procedure: chest tube drainage
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Comparing the number of days in hospital, after intervention, of each group. [ Time Frame: within one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested. [ Time Frame: within one month ] [ Designated as safety issue: Yes ]
  • Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Total costs of each patients in assigned treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: September 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Surgery: Video-assisted thoracoscopic surgery
 Procedure: Video-assisted thoracoscopic surgery
VATS for bullectomy and mechanical pleurodesis
Active Comparator: 2
Chest tube drainage
 Procedure: chest tube drainage
Chest tube drainage for pneumothroax

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 15 and 50 years old.
  2. First episode of spontaneous pneumothorax.
  3. The rim of air is > 2cm on CXR requiring simple aspiration
  4. Aspiration as the initial treatment
  5. Failed to achieve lung expansion following repeat manual aspiration

Exclusion Criteria:

  1. Complete or nearly complete and persistent lung expansion immediately following manual aspiration
  2. With underlying pulmonary disease (TB, asthma, etc)
  3. With hemothorax or tension pneumothorax requiring chest tube insertion or operation
  4. A history of previous pneumothorax
  5. A history of previous ipsilateral thoracic operation
  6. Pregnant or lactation female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713362

Contacts
Contact: Jin-Shing Chen, MD.,PhD 886-2-23123456 ext 65178 chenjs@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD     886-2-23123456 ext 5178     chenjs@ntu.edu.tw    
Principal Investigator: Jin-Shing Chen, MD, PhD            
Far Eastern Memorial Hospital Recruiting
Taipei county, Taiwan
Contact: Kung-Tsao Tsai, MD     886-917925017     hikali888@gmail.com    
Principal Investigator: Kung-Tsao Tsai, MD            
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00713362     History of Changes
Other Study ID Numbers: 200801030R
Study First Received: July 9, 2008
Last Updated: December 13, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Aspiration, chest tube, pneumothorax, thoracoscopic surgery

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013