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Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax

NCT ID: NCT00520221

Last Updated: 2007-08-23

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

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-07-31

Brief Summary

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The optimal initial management of primary spontaneous pneumothorax (PSP) remains controversial. This study was conducted to evaluate the safety and efficacy of additional minocycline pleurodesis after successful aspiration of the first episode of PSP.

Detailed Description

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Primary spontaneous pneumothorax (PSP) most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode. The high recurrence rate stimulated the development of many different therapeutic approaches, ranging from conservative treatment such as observation to more invasive therapies such as surgery, and optimal treatment of patients presenting with a first episode of PSP remains controversial. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as the first line treatment for all PSP requiring intervention because this treatment provided the advantage of reduced hospital admission rate and reduced length of hospital stay when compared with chest tube drainage. However, the recurrence rate of this procedure was around 30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Previously, chemical pleurodesis had usually been administrated through chest tube or thoracoscopy. Administration of sclerosing agents through intravenous needle catheter or pigtail catheter after simple aspiration had never been reported and the safety and efficacy remained unknown.

Because the recurrence rate after simple aspiration remains high, we began to instill minocycline into the pleural cavity through the pigtail or intravenous needle catheter since December 2005 to determine if this adjuvant is effective in reducing the rate of recurrence. In the present study, we report our experience of minocycline pleurodesis in treating first episode of PSP after successful aspiration of pneumothorax. The effects of this adjuvant therapy were evaluated by comparing the outcomes of the patients who underwent simple aspiration alone with those who underwent additional minocycline pleurodesis.

Conditions

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Pneumothorax

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Study Groups

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2

Minocycline group: 300 mg of minocycline hydrochloride was instilled into the pleural space through the catheter.

Control group consisted of 33 patients who had successful simple aspiration alone between January 2004 and December 2005.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Primary spontaneous pneumothorax patients who underwent manual aspiration as their initial treatment were selected.

Exclusion Criteria

* Patients with a previous history of spontaneous pneumothorax, \>50 years of age, or with preexisting pulmonary diseases were excluded. Patients with unsuccessful aspiration requiring further chest tube insertion or thoracoscopic operation were also excluded
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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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

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200707015R

Identifier Type: -

Identifier Source: org_study_id