Outcome of Patients Undiagnosed Under Medical Thoracoscopy

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.

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Key information

Conditions

Pleural Diseases Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pleural Effusion Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Extrapulmonary Tuberculosis, Pleural

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ESOGU Medical Faculty Department of Chest Diseases

Eskişehir, Meselik - Eskisehir, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical thoracoscopy

Procedure

Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.

Other names: Rigid thoracoscopy for diagnosis of pleural diseases

Primary outcomes

Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis.

Time frame: 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 outcomes

To determine the factors which point the false positive diagnosis of fibrinous pleuritis.

Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Outcome of Patients Who Could Not Have Been Diagnosed by Medical Thoracoscopy

Important dates

Study start: 2002
Primary completion: 2009
Study completion: 2009
First posted: May 20, 2011
Registry last updated: Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed