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Outcome of Patients Undiagnosed Under Medical Thoracoscopy

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Completed
CT.gov ID
NCT01356979
Collaborator
(none)
355
Enrollment
1
Location
88
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ? The investigators do not know the answer of this question.

In this study the investigators aimed to investigate the outcome of the patients who are diagnosed as fibrinous pleuritis on MT biopsies.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medical thoracoscopy

Detailed Description

Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases with a sensitivity above 90% and specificity of 1000% for malignant pleural diseases and pleural tuberculosis. Except these two groups of patients, in others pleural histopathological diagnosis is defined as "non-specific pleuritis" or "fibrinous pleuritis". Authors say that the natural evolution of these patients is poorly understood. Some of these patients was later established false negative cases for malignant pleural diseases. Clinical guidelines recommend close observation of patients with undiagnosed exudative effusions, although the length and follow-up regime is not defined, yet. In this study the investigators examine the outcome of patients who are diagnosed as fibrinous pleuritis by MT.

Study Design

Study Type:
Observational
Anticipated Enrollment :
355 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Outcome of Patients Who Could Not Have Been Diagnosed by Medical Thoracoscopy
Study Start Date :
Feb 1, 2002
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Patients underwent medical thoracoscopy

Patients who require medical thoracoscopy for undiagnosed exudative pleural effusion by other clinical or radiological investigations.

Procedure: Medical thoracoscopy
Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.
Other Names:
  • Rigid thoracoscopy for diagnosis of pleural diseases

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis. [2 years]

      During 2 years after medical thoracoscopy, the diagnostic sensitivity, specificity, positive predictive value and negative predictive value are determined in the patients diagnosed as fibrinous pleuritis.

    Secondary Outcome Measures

    1. To determine the factors which point the false positive diagnosis of fibrinous pleuritis. [2 years]

      The factors predictive of false-negative biopsy results in the patients with a diagnosis of fibrinous pleuritis are determined by using logistic regression analysis .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Undiagnosed exudative pleural effusion

    • Under 20 years-old, over 85 years-old

    • Followed 2 years at least

    Exclusion Criteria:

    • Transudative pleural effusion

    • Patients who do not accepted medical thoracoscopy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ESOGU Medical Faculty Department of Chest Diseases Eskisehir Meselik - Eskisehir Turkey 26040

    Sponsors and Collaborators

    • Eskisehir Osmangazi University

    Investigators

    • Principal Investigator: Muzaffer Metintas, MD, ESOGU Medical Faculty Department of Chest Diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muzaffer Metintas, MD, Prof. in Pulmonary Medicine, Eskisehir Osmangazi University
    ClinicalTrials.gov Identifier:
    NCT01356979
    Other Study ID Numbers:
    • 052011/15
    First Posted:
    May 20, 2011
    Last Update Posted:
    Sep 25, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Muzaffer Metintas, MD, Prof. in Pulmonary Medicine, Eskisehir Osmangazi University
    Medical thoracoscopy
    Pleural effusion
    Malignant pleural diseases
    Tuberculous pleuritis
    Fibrinous pleuritis
    Additional relevant MeSH terms:
    Pleural Diseases

    Study Results

    No Results Posted as of Sep 25, 2012