Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

Pneumothorax Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01463553
• Other study ID #: Z111107058811089
• Status: Recruiting
• Phase: Phase 4
• First received: October 30, 2011
• Last updated: November 10, 2013
• Start date: July 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Beijing Haidian Hospital
• Contact: Yuqing Huang, associate director
• Phone: 0861337735630
• Email: huangyuqing555[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to:

1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as evaluated from chest X-ray film, as the operative indications for video-assisted thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).

2. Through a randomized double blind controlled trial on patients whose PSP was caused by lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of recurrence of PSP and the trauma of the operation on patients.

3. Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 45 Years

Eligibility

Inclusion Criteria:

1. patients in whom obvious bullous forms are seen in PSP pneumothorax lines, or whose pneumothorax lines are rough and interrupted with or without thoracentesis, thoracic close drainage

2. patients whose lung compression exceeded 30% for the first incidence of pneumothorax

3. patients between the ages of 14 and 40, with normal vital signs (body temperature, breathing, blood pressure, pulse) and normal results on routine examination (routine blood test, liver and kidney functions)

4. no language barrier, such as surdimutism, aphasia

5. patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment

Exclusion Criteria:

1. patients who refuse VATS operation

2. patients who refuse the follow-up

3. patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases

4. patients with mental illness, low IQ, or inability to understand the informed consent

5. substance abusers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleurodesis
• Pneumothorax

Intervention

Procedure:
• VATS pleurodesis
Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.

Locations

Country	Name	City	State
China	Beijing Haidian Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Haidian Hospital	Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Primary Spontaneous Pneumothorax (PSP)	Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax	24 months	No
Secondary	Did not recurrence		24months	No