Evaluation Of Pleural Effusion At Assiut University Hospital

August 23, 2017 updated by: Nermen Abuelkassem, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Raafat T Elsokary, Prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2017

Primary Completion (Anticipated)

October 30, 2019

Study Completion (Anticipated)

January 30, 2020

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLEFF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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