Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumothorax
Intervention: 1 apical pleurectomy (Procedure); 2 pleural abrasion + minocycline pleurodesis (Procedure)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Yung-Chie Lee, MD, PhD, Study Chair, Affiliation: Department of Surgery, National Taiwan University Hospital, Taiwan
Jin-Shing Chen, MD, PhD, Study Director, Affiliation: Department of Surgery, National Taiwan University Hospital, Taiwan
Overall contact:
Yung-Chie Lee, MD, PhD, Phone: 886-2-23123456, Ext: 5070, Email: wuj@ha.mc.ntu.edu.tw
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Recurrence rate of pneumothorax after thoracoscopic operation.
Secondary outcome: The short-term results (Pain level, chest tube duration, hospital stay, etc)Complication rate Long-term results: residual pain Long-term pulmonary function test
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
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Yung-Chie Lee, MD, PhD, Phone: 886-2-23123456, Ext: 5070, Email: wuj@ha.mc.ntu.edu.tw
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Jin-Shing Chen, MD, PhD, Phone: 886-2-23123456, Ext: 5178, Email: cjs@ha.mc.ntu.edu.tw
Yung-Chie Lee, MD, PhD, Principal Investigator
Jin-Shing Chen, MD, PhD, Sub-Investigator
Additional Information
Related 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.
Starting date: April 2005
Ending date: May 2009
Last updated: August 4, 2006
|
