Outcome of Patients Undiagnosed Under Medical Thoracoscopy

Pleural Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356979
• Other study ID #: 052011/15
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: September 24, 2012
• Start date: February 2002
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pleural Diseases

Intervention

Procedure:
• Medical thoracoscopy
Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.

Locations

Country	Name	City	State
Turkey	ESOGU Medical Faculty Department of Chest Diseases	Eskisehir	Meselik - Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis.	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.	2 years	Yes
Secondary	To determine the factors which point the false positive diagnosis of fibrinous pleuritis.	The factors predictive of false-negative biopsy results in the patients with a diagnosis of fibrinous pleuritis are determined by using logistic regression analysis .	2 years	Yes