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NCT03260088 Clinical Trial

Evaluation Of Pleural Effusion At Assiut University Hospital

Pleural Effusion Clinical Trial

Official title:
Evaluation Of Pleural Effusion At Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03260088
Other study ID # PLEFF
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 17, 2017
Last updated August 23, 2017
Start date October 30, 2017
Est. completion date January 30, 2020

Study information
Verified date August 2017
Source Assiut University
Contact Raafat T Elsokary, Prof
Phone 01006155517
Email elsokkary100@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1
Est. completion date January 30, 2020
Est. primary completion date October 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients with transudative pleural effusion

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Immunoglobulin G4
IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Davies HE, Nicholson JE, Rahman NM, Wilkinson EM, Davies RJ, Lee YC. Outcome of patients with nonspecific pleuritis/fibrosis on thoracoscopic pleural biopsies. Eur J Cardiothorac Surg. 2010 Oct;38(4):472-7. doi: 10.1016/j.ejcts.2010.01.057. Epub 2010 Mar 12. — View Citation

Della-Torre E, Lanzillotta M, Doglioni C. Immunology of IgG4-related disease. Clin Exp Immunol. 2015 Aug;181(2):191-206. doi: 10.1111/cei.12641. Epub 2015 Jun 8. Review. — View Citation

Ferrer JS, Muñoz XG, Orriols RM, Light RW, Morell FB. Evolution of idiopathic pleural effusion: a prospective, long-term follow-up study. Chest. 1996 Jun;109(6):1508-13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital 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. one year
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