Pathogenesis of Primary Spontaneous Pneumothorax

• ClinicalTrials.gov Identifier: NCT01135004
• Recruitment Status: Unknown
• First Posted: June 2, 2010
• Last Update Posted: June 2, 2010
• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital, Yun-Lin Branch; National Science Council, Taiwan
• Information provided by: National Taiwan University Hospital

Tracking Information

• First Submitted Date: May 30, 2010
• First Posted Date: June 2, 2010
• Last Update Posted Date: June 2, 2010
• Study Start Date: March 2010
• Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pathogenesis of Primary Spontaneous Pneumothorax
• Official Title: Molecular Pathogenesis of Primary Spontaneous Pneumothorax
• Brief Summary: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.
• Detailed Description: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients. The blebs resected from the pneumothorax patients will be used for RNA and protein levels analyses. The adjacent normal lung tissue will be used as a control for comparison.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Thoracoscopic bullectomy will be performed in spontaneous pneumothorax patients. Part of the surgcal specimen (lung tissue) will be obtained for RNA and protein analyses.

• Sampling Method: Non-Probability Sample
• Study Population: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.
• Condition: Pneumothorax

Intervention

Procedure: Thoracoscopic bullectomy

Thoracoscopic wedge resection of the diseased lung

Other Name: Video-assisted thoracic surgery (VATS)

Study Groups/Cohorts

Pneumothorax patients

Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy

Intervention: Procedure: Thoracoscopic bullectomy

• Publications *: Ayed AK, Chandrasekaran C, Sukumar M. Video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: clinicopathological correlation. Eur J Cardiothorac Surg. 2006 Feb;29(2):221-5. Epub 2005 Dec 20.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 1, 2010): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2013
• Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age between 14 and 40 years
• Spontaneous pneumothorax
• Underwent bullectomy of the lung

Exclusion Criteria:

• With underlying lung disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01135004
• Other Study ID Numbers: 200912060R
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yung-Chie Lee, Professor, National Taiwan University Hospital
• Study Sponsor: National Taiwan University Hospital

Collaborators

• National Taiwan University Hospital, Yun-Lin Branch
• National Science Council, Taiwan

Investigators

• Study Chair: Yung-Chie Lee, MD, PhD; National Taiwan University Hospital

• PRS Account: National Taiwan University Hospital
• Verification Date: March 2010