Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax - Full Text View

Sponsor:	National Taiwan University Hospital
Collaborator:	National Science Council, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00270751

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 II Phase III

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:

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

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

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:

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. 2005 Dec 15; [Epub ahead of print]

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.

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012