Pathogenesis of Primary Spontaneous Pneumothorax

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01135004
• Collaborator: National Taiwan University Hospital, Yun-Lin Branch (Other), National Science Council, Taiwan (Other)
• Enrollment: 30
• Location: 1
• Duration (Months): 35.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumothorax	Procedure: Thoracoscopic bullectomy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Molecular Pathogenesis of Primary Spontaneous Pneumothorax
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2012
• Anticipated Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Pneumothorax patients Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy	Procedure: Thoracoscopic bullectomy; Thoracoscopic wedge resection of the diseased lung; Other Names: Video-assisted thoracic surgery (VATS)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 14 and 40 years

• Spontaneous pneumothorax

• Underwent bullectomy of the lung

Exclusion Criteria:

• With underlying lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT01135004
• Other Study ID Numbers: 200912060R
• First Posted: Jun 2, 2010
• Last Update Posted: Jun 2, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: pneumothorax; thoracoscopy; pathogenesis; blebs; surgery
• Additional relevant MeSH terms: Pneumothorax

Study Results

No Results Posted as of Jun 2, 2010