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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: July 9, 2008
Last updated: December 13, 2012
Last verified: November 2012

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
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00713362

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 5178   
Principal Investigator: Jin-Shing Chen, MD, PhD         
Far Eastern Memorial Hospital Recruiting
Taipei county, Taiwan
Contact: Kung-Tsao Tsai, MD    886-917925017   
Principal Investigator: Kung-Tsao Tsai, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital 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:
Pleural Diseases
Respiratory Tract Diseases processed this record on October 08, 2015