Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00270751
First received: December 26, 2005
Last updated: August 4, 2006
Last verified: August 2006
  Purpose

Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.


Condition Intervention Phase
Pneumothorax
Procedure: 1 apical pleurectomy
Procedure: 2 pleural abrasion + minocycline pleurodesis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pleural Abrasion Plus Minocycline Pleurodesis Versus Apical Pleurectomy After Thoracoscopic Bullectomy for High Recurrent Risk Patients With Primary Spontaneous Pneumothorax: A Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Recurrence rate of pneumothorax after thoracoscopic operation.

Secondary Outcome Measures:
  • The short-term results (Pain level, chest tube duration, hospital stay, etc)
  • Complication rate
  • Long-term results: residual pain
  • Long-term pulmonary function test

Estimated Enrollment: 200
Study Start Date: April 2005
Estimated Study Completion Date: May 2009
Detailed Description:

Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation

Exclusion Criteria:

  • With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270751

Contacts
Contact: Yung-Chie Lee, MD, PhD 886-2-23123456 ext 5070 wuj@ha.mc.ntu.edu.tw
Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 5178 cjs@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD    886-2-23123456 ext 5178    cjs@ha.mc.ntu.edu.tw   
Principal Investigator: Yung-Chie Lee, MD, PhD         
Sub-Investigator: Jin-Shing Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Yung-Chie Lee, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
Study Director: Jin-Shing Chen, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00270751     History of Changes
Other Study ID Numbers: 31MD02
Study First Received: December 26, 2005
Last Updated: August 4, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Video-Assisted Thoracoscopic Surgery
Spontaneous pneumothorax
Pleurectomy
Pleural abrasion
Minocycline

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014