Outcome of Patients Undiagnosed Under Medical Thoracoscopy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01356979

Enrollment

355

Registered

2011-05-20

Start date

2002-02-28

Completion date

2009-06-30

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Diseases

Keywords

Medical thoracoscopy, Pleural effusion, Malignant pleural diseases, Tuberculous pleuritis, Fibrinous pleuritis

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.

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.

Interventions

PROCEDUREMedical thoracoscopy

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 .

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026