Improving Primary Spontaneous Pneumothorax (PSP) Treatment Techniques in VATS

This study is currently recruiting participants.
Verified November 2013 by Beijing Haidian Hospital
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Huang Yuqing, Beijing Haidian Hospital
ClinicalTrials.gov Identifier:
NCT01463553
First received: October 30, 2011
Last updated: November 10, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Beijing Haidian Hospital:

Primary Outcome Measures:
  • Recurrence of Primary Spontaneous Pneumothorax (PSP) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax


Secondary Outcome Measures:
  • Did not recurrence [ Time Frame: 24months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   10 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Huang Yuqing, Deputy Director, Beijing Haidian Hospital
ClinicalTrials.gov Identifier: NCT01463553     History of Changes
Other Study ID Numbers: Z111107058811089
Study First Received: October 30, 2011
Last Updated: November 10, 2013
Health Authority: China: Beijing Municipal Science and Technology Commission

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

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014