Clinical trial NCT01463553: Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumothorax
Pleurodesis
Keywords: primary spontaneous pneumothorax
VATS
pleurodesis
recurrence rate
Lead sponsor: Beijing Haidian Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
First posted: 2011-11-02
Enrollment: 320
Sex: ALL
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of Primary Spontaneous Pneumothorax (PSP)
timeFrame: 24 months
Secondary outcomes:
measure: Did not recurrence
timeFrame: 24months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital
state: Beijing
Study officials:
affiliation: Peking University People Hospital
name: Jun Liu, associate director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min X, Huang Y, Yang Y, Chen Y, Cui J, Wang C, Huang Y, Liu J, Wang J. Mechanical pleurodesis does not reduce recurrence of spontaneous pneumothorax: a randomized trial. Ann Thorac Surg. 2014 Nov;98(5):1790-6; discussion 1796. doi: 10.1016/j.athoracsur.2014.06.034. Epub 2014 Sep 16.