Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax

August 22, 2007 updated by: National Taiwan University Hospital

Intrapleural Minocycline Following Simple Aspiration for Initial Treatment of Primary Spontaneous Pneumothorax: a Retrospective Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200707015R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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