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Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Huang Yuqing, Beijing Haidian Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463553
First Posted: November 2, 2011
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Huang Yuqing, Beijing Haidian Hospital
  Purpose

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.

Condition Intervention Phase
Pneumothorax Pleurodesis Procedure: VATS pleurodesis Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Huang Yuqing, Beijing Haidian Hospital:

Primary Outcome Measures:
  • Recurrence of Primary Spontaneous Pneumothorax (PSP) [ Time Frame: 24 months ]
    Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax


Secondary Outcome Measures:
  • Did not recurrence [ Time Frame: 24months ]

Estimated Enrollment: 320
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: wedge resection
Experimental: Wedge resection and pleurodosis 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463553


Contacts
Contact: Yuqing Huang, associate director 0861337735630 huangyuqing555@gmail.com
Contact: Jun liu, associate director 08613601249585 liujundaifu@yahoo.cn

Locations
China, Beijing
Beijing Haidian Hospital Recruiting
Beijing, Beijing, China, 100080
Contact: Xu Wang, Director    62583013    hdyykj@sina.com   
Sponsors and Collaborators
Beijing Haidian Hospital
Peking University People's Hospital
Investigators
Principal Investigator: Jun Liu, associate director Peking University People Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Huang Yuqing, Deputy Director, Beijing Haidian Hospital
ClinicalTrials.gov Identifier: NCT01463553     History of Changes
Other Study ID Numbers: Z111107058811089
First Submitted: October 30, 2011
First Posted: November 2, 2011
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Huang Yuqing, Beijing Haidian Hospital:
primary spontaneous pneumothorax
VATS
pleurodesis
recurrence rate

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases