Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
Primary Purpose
Pneumothorax, Pleurodesis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
VATS pleurodesis
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax focused on measuring primary spontaneous pneumothorax, VATS, pleurodesis, recurrence rate
Eligibility Criteria
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
Sites / Locations
- Beijing Haidian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
wedge resection
Wedge resection and pleurodosis
Arm Description
Outcomes
Primary Outcome Measures
Recurrence of Primary Spontaneous Pneumothorax (PSP)
Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax
Secondary Outcome Measures
Did not recurrence
Full Information
NCT ID
NCT01463553
First Posted
October 30, 2011
Last Updated
November 10, 2013
Sponsor
Beijing Haidian Hospital
Collaborators
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01463553
Brief Title
Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Haidian Hospital
Collaborators
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Pleurodesis
Keywords
primary spontaneous pneumothorax, VATS, pleurodesis, recurrence rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wedge resection
Arm Type
No Intervention
Arm Title
Wedge resection and pleurodosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
VATS pleurodesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of Primary Spontaneous Pneumothorax (PSP)
Description
Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Did not recurrence
Time Frame
24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqing Huang, associate director
Phone
0861337735630
Email
huangyuqing555@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun liu, associate director
Phone
08613601249585
Email
liujundaifu@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Liu, associate director
Organizational Affiliation
Peking University People Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Haidian Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Wang, Director
Phone
62583013
Email
hdyykj@sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25236367
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.
Results Reference
derived
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Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS
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