- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463553
Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
November 10, 2013 updated by: Huang Yuqing, Beijing Haidian Hospital
The purpose of this study is to:
- 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).
- 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.
- 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
320
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuqing Huang, associate director
- Phone Number: 0861337735630
- Email: huangyuqing555@gmail.com
Study Contact Backup
- Name: Jun liu, associate director
- Phone Number: 08613601249585
- Email: liujundaifu@yahoo.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100080
- Recruiting
- Beijing Haidian Hospital
-
Contact:
- Xu Wang, Director
- Phone Number: 62583013
- Email: hdyykj@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 45 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- patients whose lung compression exceeded 30% for the first incidence of pneumothorax
- 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)
- no language barrier, such as surdimutism, aphasia
- patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment
Exclusion Criteria:
- patients who refuse VATS operation
- patients who refuse the follow-up
- patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
- patients with mental illness, low IQ, or inability to understand the informed consent
- substance abusers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: wedge resection
|
|
EXPERIMENTAL: Wedge resection and pleurodosis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of Primary Spontaneous Pneumothorax (PSP)
Time Frame: 24 months
|
Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Did not recurrence
Time Frame: 24months
|
24months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun Liu, associate director, Peking University People Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ANTICIPATED)
November 1, 2013
Study Completion (ANTICIPATED)
November 1, 2013
Study Registration Dates
First Submitted
October 30, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (ESTIMATE)
November 2, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 13, 2013
Last Update Submitted That Met QC Criteria
November 10, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z111107058811089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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