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Outcome of Patients Undiagnosed Under Medical Thoracoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Muzaffer Metintas, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT01356979
First received: May 16, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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 Intervention
Pleural Diseases
Procedure: Medical thoracoscopy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Outcome of Patients Who Could Not Have Been Diagnosed by Medical Thoracoscopy

Resource links provided by NLM:


Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • To determine the factors which point the false positive diagnosis of fibrinous pleuritis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The factors predictive of false-negative biopsy results in the patients with a diagnosis of fibrinous pleuritis are determined by using logistic regression analysis .


Estimated Enrollment: 355
Study Start Date: February 2002
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Rigid thoracoscopy for diagnosis of pleural diseases

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients with undiagnosed exudative pelural effusion by clinical, radiological or laboratory investigations.

Criteria

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
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: NCT01356979

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Muzaffer Metintas, MD, Prof. in Pulmonary Medicine, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT01356979     History of Changes
Other Study ID Numbers: 052011/15
Study First Received: May 16, 2011
Last Updated: September 24, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
Medical thoracoscopy
Pleural effusion
Malignant pleural diseases
Tuberculous pleuritis
Fibrinous pleuritis

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 19, 2014