NCT01135004

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 2, 2010

Status Verified

March 1, 2010

Enrollment Period

1.9 years

First QC Date

May 30, 2010

Last Update Submit

June 1, 2010

Conditions

Keywords

pneumothoraxthoracoscopypathogenesisblebssurgery

Study Arms (1)

Pneumothorax patients

Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy

Procedure: Thoracoscopic bullectomy

Interventions

Thoracoscopic wedge resection of the diseased lung

Also known as: Video-assisted thoracic surgery (VATS)
Pneumothorax patients

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • With underlying lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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. doi: 10.1016/j.ejcts.2005.11.005. Epub 2005 Dec 20.

    PMID: 16376095BACKGROUND

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.

MeSH Terms

Conditions

PneumothoraxBlister

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesSkin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Yung-Chie Lee, MD, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Jin-Shing Chen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2010

First Posted

June 2, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2013

Last Updated

June 2, 2010

Record last verified: 2010-03

Locations