Pleural Diseases Clinical Trial
Official title:
Safety of Thoracoscopy in Patients With High Risk
Verified date | September 2012 |
Source | Eskisehir Osmangazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 355 |
Est. completion date | December 2010 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients with exudative pleural effusion Exclusion Criteria: - Patients without pleural effusion |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Turkey | ESOGU | Eskisehir |
Lead Sponsor | Collaborator |
---|---|
Eskisehir Osmangazi University |
Turkey,
Rodríguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 12. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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. | 6 years | Yes |
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