Outcome of Patients Undiagnosed Under Medical Thoracoscopy

Outcome of Patients Who Could Not Have Been Diagnosed by 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.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 355

Contacts and Locations

Study Locations

• Turkey
  • Meselik - Eskisehir
    • Eskisehir, Meselik - Eskisehir, Turkey, 26040
      • ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Muzaffer Metintas, MD, ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Medical thoracoscopy; Pleural effusion; Malignant pleural diseases; Tuberculous pleuritis; Fibrinous pleuritis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases
• Other Study ID Numbers: 052011/15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No