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Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463553
Enrollment
320
Registered
2011-11-02
Start date
2011-07-31
Completion date
2013-11-30
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleurodesis, Pneumothorax

Keywords

primary spontaneous pneumothorax, VATS, pleurodesis, recurrence rate

Brief 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.

Interventions

PROCEDUREVATS 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.

Sponsors

Peking University People's Hospital
CollaboratorOTHER
Beijing Haidian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of Primary Spontaneous Pneumothorax (PSP)24 monthsMonitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax

Secondary

MeasureTime frame
Did not recurrence24months

Countries

China

Contacts

Primary ContactYuqing Huang, associate director
huangyuqing555@gmail.com0861337735630
Backup ContactJun liu, associate director
liujundaifu@yahoo.cn08613601249585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026