Evaluation Of Pleural Effusion At Assiut University Hospital

NCT ID: NCT03260088

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Pleural Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with pleural effusion

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

Immunoglobulin G4

Intervention Type DIAGNOSTIC_TEST

IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry

Interventions

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Immunoglobulin G4

IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nermen Abuelkassem

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raafat T Elsokary, Prof

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Raafat T Elsokary, Prof

Role: CONTACT

01006155517

Ahmed Metwally, Dr.

Role: CONTACT

01002163907

References

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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.

Reference Type BACKGROUND
PMID: 25865251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20219385 (View on PubMed)

Ferrer JS, Munoz 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. doi: 10.1378/chest.109.6.1508.

Reference Type BACKGROUND
PMID: 8769502 (View on PubMed)

Other Identifiers

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PLEFF

Identifier Type: -

Identifier Source: org_study_id

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