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Evaluation Of Pleural Effusion At Assiut University Hospital

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ClinicalTrials.gov Identifier: NCT03260088
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Nermen Abuelkassem, 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.

Condition or disease Intervention/treatment
Pleural Effusion Diagnostic Test: Immunoglobulin G4

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 Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Of Pleural Effusion At Assiut University Hospital
Estimated Study Start Date : October 30, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with pleural effusion
In patients with pleural effusion that remains undiagnosed with common diagnostic algorithm, immunoglobulin G4 will be done in pleural fluid
Diagnostic Test: Immunoglobulin G4
IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry




Primary Outcome Measures :
  1. diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with exudative pleural effusion admitted to Assiut university hospital in period of October 2017 to October 2018
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260088


Contacts
Contact: Raafat T Elsokary, Prof 01006155517 elsokkary100@yahoo.com
Contact: Ahmed Metwally, Dr. 01002163907 ahmed_80metwally@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Study Director: Raafat T Elsokary, Prof Assiut University

Publications:
Responsible Party: Nermen Abuelkassem, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03260088     History of Changes
Other Study ID Numbers: PLEFF
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Immunoglobulins
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs