Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00520221
First received: August 21, 2007
Last updated: August 22, 2007
Last verified: January 2004
  Purpose

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.


Condition
Pneumothorax

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Intrapleural Minocycline Following Simple Aspiration for Initial Treatment of Primary Spontaneous Pneumothorax: a Retrospective Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Enrollment: 64
Study Start Date: January 2004
Study Completion Date: July 2007
Groups/Cohorts
Treatment Comparison: 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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520221

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520221     History of Changes
Other Study ID Numbers: 200707015R
Study First Received: August 21, 2007
Last Updated: August 22, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
minocycline
pleurodesis
aspiration
pneumothorax
Primary spontaneous pneumothorax
First attack
Successful aspiration

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014