Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax - Full Text View

Sponsors and Collaborators:	National Taiwan University Hospital Department of Health, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00713362

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 II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial

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
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Surgery: Video-assisted thoracoscopic surgery	Procedure: Video-assisted thoracoscopic surgery VATS for bullectomy and mechanical pleurodesis
2: Active Comparator Chest tube drainage	Procedure: chest tube drainage Chest tube drainage for pneumothroax

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Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Complete or nearly complete and persistent lung expansion immediately following manual aspiration
With underlying pulmonary disease (TB, asthma, etc)
With hemothorax or tension pneumothorax requiring chest tube insertion or operation
A history of previous pneumothorax
A history of previous ipsilateral thoracic operation
Pregnant or lactation female

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713362

Contacts

Contact: Yung-Chie Lee, MD.,PhD

886-2-23123456 ext 5070

yclee@ntuh.gov.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: Yung-Chie Lee, MD, PhD
Sub-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, Taiwan

Investigators

Study Chair:

Yung-Chie Lee, MD, PhD

National Taiwan University Hospital

More Information

Responsible Party:	Division of Thoracic Surgery, National Taiwan University Hospital ( Yung-Chie Lee )
Study ID Numbers:	200801030R
Study First Received:	July 9, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00713362
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Aspiration, chest tube, pneumothorax, thoracoscopic surgery

Study placed in the following topic categories:

Respiratory Tract Diseases
Pleural Diseases
Pneumothorax

ClinicalTrials.gov processed this record on January 14, 2009