MedDataX Logo

Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

NCT ID: NCT00270751

Last Updated: 2006-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumothorax

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Video-Assisted Thoracoscopic Surgery Spontaneous pneumothorax Pleurectomy Pleural abrasion Minocycline

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1 apical pleurectomy

Intervention Type PROCEDURE

2 pleural abrasion + minocycline pleurodesis

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yung-Chie Lee, MD, PhD

Role: STUDY_CHAIR

Department of Surgery, National Taiwan University Hospital, Taiwan

Jin-Shing Chen, MD, PhD

Role: STUDY_DIRECTOR

Department of Surgery, National Taiwan University Hospital, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yung-Chie Lee, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Jin-Shing Chen, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jin-Shing Chen, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16357330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14718420 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22323011 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

31MD02

Identifier Type: -

Identifier Source: org_study_id