Pathogenesis of Primary Spontaneous Pneumothorax

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Taiwan University Hospital, Yun-Lin Branch
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01135004
First received: May 30, 2010
Last updated: June 1, 2010
Last verified: March 2010
  Purpose

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 Intervention
Pneumothorax
Procedure: Thoracoscopic bullectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Pathogenesis of Primary Spontaneous Pneumothorax

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pneumothorax patients
Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy
Procedure: Thoracoscopic bullectomy
Thoracoscopic wedge resection of the diseased lung
Other Name: Video-assisted thoracic surgery (VATS)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • With underlying lung disease
  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 ClinicalTrials.gov identifier: NCT01135004

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 65178    chenjs@ntu.edu.tw   
Principal Investigator: Yung-Chie Lee, MD, PhD         
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
  More Information

Publications:
Responsible Party: Yung-Chie Lee, Professor, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01135004     History of Changes
Other Study ID Numbers: 200912060R
Study First Received: May 30, 2010
Last Updated: June 1, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
pneumothorax
thoracoscopy
pathogenesis
blebs
surgery

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014