Evaluation Of Pleural Effusion At Assiut University Hospital

• Conditions: Pleural Effusion
• Interventions: Diagnostic Test: Immunoglobulin G4

• Registration Number: NCT03260088
• Lead Sponsor: Assiut University

Brief Summary

Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized countries. The cause of the pleural effusion remains unclear in a substantial percentage of patients with persistently exudative effusions.

Detailed Description

They are classified broadly into exudative and transudative effusion based on Light's criteria.

Several methods have been proposed for the identification of pleural effusion etiology including pleural fluid cytology, pleural biopsy, thoracoscopy and computerized tomography. However, these technologies have their own limitations.

The diagnosis of malignant pleural effusion is a vexing problem, since pleural fluid cytology findings are positive in only 60% of cases on average. Tumor marker carcinoembryonic antigen (CEA) can be positive in 80% of cases.

Thoracoscopy will establish the diagnosis in approximately 95% of cases, but this interventional procedure may not be available at all facilities.

A new approach is needed to detect the cause of undiagnosed pleural effusions. Diagnosis of idiopathic pleural effusion was made after a minimum of one year follow up with detailed exploration including computed tomographic scanning to exclude other causes of effusion such as malignant pleural effusion.

Because immunoglobulin G4 (IgG4)-related disease is recognized as a fibroinflammatory condition of unknown cause that can affect multiple organs including the lungs and pleura, IgG4 might be related to certain idiopathic pleural effusions.

The criteria of Common radiological findings of IgG4-related lung disease include hilar and mediastinal lymphadenopathy, thickening of perilymphatic interstitium with or without subpleural and/or peribronchovascular consolidation.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-23
• Last Update Submitted: 2017-08-23
• Study First Posted: 2017-08-24
• Last Update Posted: 2017-08-24
• Study Start: 2017-10-30
• Primary Completion: 2019-10-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• All patients with exudative pleural effusion admitted to Assiut university hospital in period of October 2017 to October 2018

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Exclusion Criteria

• Patients with transudative pleural effusion

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with pleural effusion	Immunoglobulin G4	In patients with pleural effusion that remains undiagnosed with common diagnostic algorithm, immunoglobulin G4 will be done in pleural fluid

Primary Outcome Measures

Name	Time	Method
diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital	one year	Immunoglobulin G4 will be puified from pleural fluids by diethylaminoetyyl cellulose ion exchange nephlometry in patients with undiagnosed effusion after common investigations as it positive in IgG4 related disease. The median effusion IgG4 level was 41mg/dl in the IgG4 positive group and 27mg/dl in the IgG negative group.