Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

• ClinicalTrials.gov Identifier: NCT00270751
• Recruitment Status: Unknown
• First Posted: December 28, 2005
• Last Update Posted: August 7, 2006
• Sponsor: National Taiwan University Hospital
• Collaborator: National Science Council, Taiwan
• Information provided by: National Taiwan University Hospital

Tracking Information

• First Submitted Date: December 26, 2005
• First Posted Date: December 28, 2005
• Last Update Posted Date: August 7, 2006
• Study Start Date: April 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: December 26, 2005): Recurrence rate of pneumothorax after thoracoscopic operation.
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00270751 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 4, 2006)

• The short-term results (Pain level, chest tube duration, hospital stay, etc)
• Complication rate
• Long-term results: residual pain
• Long-term pulmonary function test

Original Secondary Outcome Measures (submitted: December 26, 2005)

• 1. The short-term results (Pain level, chest tube duration, hospital stay, etc)
• 2. Complication rate
• 3. Long-term results: residual pain
• 4. Long-term pulmonary function test

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pneumothorax

Intervention

• Procedure: 1 apical pleurectomy
• Procedure: 2 pleural abrasion + minocycline pleurodesis

• Study Arms: Not Provided

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. 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: December 26, 2005): 200
• Original Enrollment: Same as current
• Study Completion Date: May 2009
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00270751
• Other Study ID Numbers: 31MD02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: National Taiwan University Hospital
• Collaborators: 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

• PRS Account: National Taiwan University Hospital
• Verification Date: August 2006