Pleural Abrasion Plus Minocycline Versus Apical Pleurecto... | NCT00270751

Studies
Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

NCT00270751

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 7, 2006Estimated

Enrollment

200

Phase

Phase 2Phase 3

Conditions

Pneumothorax

Interventions

1 apical pleurectomy
2 pleural abrasion + minocycline pleurodesis

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

May 2009

First Submitted Date

Dec 26, 2005

First Submission Date that Met QC Criteria

Dec 26, 2005

First Posted Date

Dec 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2006

Last Update Posted Date

Aug 7, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate of pneumothorax after thoracoscopic operation.

Secondary Outcomes

Measure	Description	Time Frame
The short-term results (Pain level, chest tube duration, hospital stay, etc)
Complication rate
Long-term results: residual pain

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yung-Chie Lee, MD, PhD	Contact	886-2-23123456	5070	wuj@ha.mc.ntu.edu.tw
Jin-Shing Chen, MD, PhD	Contact	886-2-23123456	5178	cjs@ha.mc.ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yung-Chie Lee, MD, PhD	Department of Surgery, National Taiwan University Hospital, Taiwan	Study Chair
Jin-Shing Chen, MD, PhD	Department of Surgery, National Taiwan University Hospital, Taiwan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16357330	Background	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.
14718420	Background	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.

ID	Term
D011030	Pneumothorax
C562573	cyclopia sequence

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases

Name	Type	Description	Arm Group Labels	Other Names
1 apical pleurectomy	Procedure
2 pleural abrasion + minocycline pleurodesis	Procedure