NCT00270751

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 7, 2006

Status Verified

August 1, 2006

First QC Date

December 26, 2005

Last Update Submit

August 4, 2006

Conditions

Pneumothorax

Keywords

Video-Assisted Thoracoscopic SurgerySpontaneous pneumothoraxPleurectomyPleural abrasionMinocycline

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of pneumothorax after thoracoscopic operation.

Secondary Outcomes (4)

  • The short-term results (Pain level, chest tube duration, hospital stay, etc)

  • Complication rate

  • Long-term results: residual pain

  • Long-term pulmonary function test

Interventions

1 apical pleurectomyPROCEDURE
2 pleural abrasion + minocycline pleurodesisPROCEDURE

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation

You may not qualify if:

  • With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16357330BACKGROUND

  • 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.

    PMID: 14718420BACKGROUND

  • 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.

    PMID: 22323011DERIVED

MeSH Terms

Conditions

Pneumothoraxcyclopia sequence

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Yung-Chie Lee, MD, PhD

    Department of Surgery, National Taiwan University Hospital, Taiwan

    STUDY CHAIR

  • Jin-Shing Chen, MD, PhD

    Department of Surgery, National Taiwan University Hospital, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Yung-Chie Lee, MD, PhD

CONTACT

886-2-23123456wuj@ha.mc.ntu.edu.tw

Jin-Shing Chen, MD, PhD

CONTACT

886-2-23123456cjs@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2005

First Posted

December 28, 2005

Study Start

April 1, 2005

Study Completion

May 1, 2009

Last Updated

August 7, 2006

Record last verified: 2006-08

Locations

TW(1)