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Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

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.

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00270751
Enrollment
200
Registered
2005-12-28
Start date
2005-04-30
Completion date
2009-05-31
Last updated
2006-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumothorax

Keywords

Video-Assisted Thoracoscopic Surgery, Spontaneous pneumothorax, Pleurectomy, Pleural abrasion, Minocycline

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.

Interventions

PROCEDURE1 apical pleurectomy
PROCEDURE2 pleural abrasion + minocycline pleurodesis

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrence rate of pneumothorax after thoracoscopic operation.

Secondary

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

Countries

Taiwan

Contacts

Primary ContactYung-Chie Lee, MD, PhD
wuj@ha.mc.ntu.edu.tw886-2-23123456
Backup ContactJin-Shing Chen, MD, PhD
cjs@ha.mc.ntu.edu.tw886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026