Safety of Thoracoscopy in Patients With High Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193439
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : September 25, 2012
Information provided by (Responsible Party):
Muzaffer Metintas, Eskisehir Osmangazi University

Brief Summary:
Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.

Condition or disease
Pleural Diseases

Study Type : Observational
Actual Enrollment : 355 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety of Thoracoscopy in Patients With High Risk
Study Start Date : January 2002
Actual Primary Completion Date : January 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Patients with high risk
Patients in normal conditions

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 years ]
    All participants will have been followed for side effects of medical thoracoscopy. All side effects established in the special forms designed for this study. Side effects measured and recorded according to each characteristic such as pain, air leakege, pneumothorax, empyema, local infection, haemorragy etc.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who require thoracoscpic investigation

Inclusion Criteria:

  • Patients with exudative pleural effusion

Exclusion Criteria:

  • Patients without pleural effusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01193439

Eskisehir, Turkey
Sponsors and Collaborators
Eskisehir Osmangazi University
Principal Investigator: Muzaffer Metintas, Professor Head of Department, Professor of pulmonary medicine

Responsible Party: Muzaffer Metintas, MD, Eskisehir Osmangazi University Identifier: NCT01193439     History of Changes
Other Study ID Numbers: 082010/1
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Muzaffer Metintas, Eskisehir Osmangazi University:
pleural diseases

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases