- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270751
Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax
August 4, 2006 updated by: National Taiwan University Hospital
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
200
Phase
- Phase 2
- Phase 3
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: Yung-Chie Lee, MD, PhD
- Phone Number: 5070 886-2-23123456
- Email: wuj@ha.mc.ntu.edu.tw
Study Contact Backup
- Name: Jin-Shing Chen, MD, PhD
- Phone Number: 5178 886-2-23123456
- Email: cjs@ha.mc.ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Jin-Shing Chen, MD, PhD
- Phone Number: 5178 886-2-23123456
- Email: cjs@ha.mc.ntu.edu.tw
-
-
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
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Recurrence rate of pneumothorax after thoracoscopic operation.
|
Secondary Outcome Measures
Outcome Measure |
---|
Complication rate
|
The short-term results (Pain level, chest tube duration, hospital stay, etc)
|
Long-term results: residual pain
|
Long-term pulmonary function test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
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.
General Publications
- Chen JS, Hsu HH, Chen RJ, Kuo SW, Huang PM, Tsai PR, Lee JM, Lee YC. Additional minocycline pleurodesis after thoracoscopic surgery for primary spontaneous pneumothorax. Am J Respir Crit Care Med. 2006 Mar 1;173(5):548-54. doi: 10.1164/rccm.200509-1414OC. Epub 2005 Dec 15.
- Chen JS, Hsu HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Effects of additional minocycline pleurodesis after thoracoscopic procedures for primary spontaneous pneumothorax. Chest. 2004 Jan;125(1):50-5. doi: 10.1378/chest.125.1.50.
- Chen JS, Hsu HH, Huang PM, Kuo SW, Lin MW, Chang CC, Lee JM. Thoracoscopic pleurodesis for primary spontaneous pneumothorax with high recurrence risk: a prospective randomized trial. Ann Surg. 2012 Mar;255(3):440-5. doi: 10.1097/SLA.0b013e31824723f4.
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
April 1, 2005
Study Completion
May 1, 2009
Study Registration Dates
First Submitted
December 26, 2005
First Submitted That Met QC Criteria
December 26, 2005
First Posted (Estimate)
December 28, 2005
Study Record Updates
Last Update Posted (Estimate)
August 7, 2006
Last Update Submitted That Met QC Criteria
August 4, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31MD02
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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