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Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

Primary Purpose

Pneumothorax

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
1 apical pleurectomy
2 pleural abrasion + minocycline pleurodesis
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Video-Assisted Thoracoscopic Surgery, Spontaneous pneumothorax, Pleurectomy, Pleural abrasion, Minocycline

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

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

Full Information

First Posted
December 26, 2005
Last Updated
August 4, 2006
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00270751
Brief Title
Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Video-Assisted Thoracoscopic Surgery, Spontaneous pneumothorax, Pleurectomy, Pleural abrasion, Minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
1 apical pleurectomy
Intervention Type
Procedure
Intervention Name(s)
2 pleural abrasion + minocycline pleurodesis
Primary Outcome Measure Information:
Title
Recurrence rate of pneumothorax after thoracoscopic operation.
Secondary Outcome Measure Information:
Title
The short-term results (Pain level, chest tube duration, hospital stay, etc)
Title
Complication rate
Title
Long-term results: residual pain
Title
Long-term pulmonary function test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Chie Lee, MD, PhD
Phone
886-2-23123456
Ext
5070
Email
wuj@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
5178
Email
cjs@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Chie Lee, MD, PhD
Organizational Affiliation
Department of Surgery, National Taiwan University Hospital, Taiwan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Organizational Affiliation
Department of Surgery, National Taiwan University Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
5178
Email
cjs@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yung-Chie Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16357330
Citation
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.
Results Reference
background
PubMed Identifier
14718420
Citation
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.
Results Reference
background
PubMed Identifier
22323011
Citation
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.
Results Reference
derived

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Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

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