An observational study in Pleural Effusion, Transudative Pleural Effusion and Exudative Pleural Effusion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Assiut University · Observational
Pleural effusion is a condition where excess fluid builds up in the space between the lungs and the chest wall. To properly treat this condition, doctors must determine if the fluid is a "transudate" (usually resulting from systemic conditions like heart failure or liver disease) or an "exudate" (often resulting from local issues like infections, inflammation, or cancer). The standard method to classify this fluid involves inserting a needle into the chest to draw out a sample for laboratory testing, a procedure known as thoracentesis.
While laboratory fluid analysis is highly accurate, the needle procedure carries some inherent procedural risks. This observational study aims to evaluate whether non-invasive imaging tests, specifically chest ultrasound, can accurately determine if the fluid is a transudate or an exudate.
Researchers will enroll adult patients presenting with pleural effusion at Assiut University Hospital. As part of their diagnostic workup, participants will undergo a chest ultrasound and a standard diagnostic thoracentesis (fluid draw) within 24 to 48 hours of each other. The study will then evaluate the features seen on the ultrasound against the laboratory fluid analysis (the current gold standard) to see how well the non-invasive imaging performs in identifying the specific type of pleural effusion.
Pleural effusion is a highly prevalent pleural space disorder and a fundamental step in its clinical workup is determining whether the fluid is a transudate or an exudate. The standard biochemical tool for this classification is Light's criteria, which requires invasive thoracentesis. Given the procedural risks of thoracentesis and the fact that Light's criteria can misclassify up to 25% of transudates as exudates in patients on diuretic therapy, there is a need to establish the diagnostic value of non-invasive imaging modalities like thoracic ultrasound (TUS).
All enrolled participants will undergo a systematic clinical evaluation and three primary diagnostic assessments:
Clinical Evaluation:
Chest Ultrasound (TUS):
Reference Standard (Thoracentesis):
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 90 is below the median of 140 across 93 observational studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study population comprises adult patients (18 years or older) of both sexes presenting with a clinically and radiologically confirmed pleural effusion (unilateral or bilateral). Participants will be recruited from patients admitted to the Chest Medicine Department or referred for imaging at Assiut University Hospital. Eligible participants are those scheduled to undergo diagnostic thoracentesis and ultrasound of the chest as part of their standard clinical diagnostic workup.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (18 years or older) presenting with clinically and radiologically confirmed pleural effusion. All participants in this cohort will undergo a chest ultrasound and a diagnostic thoracentesis within 24 to 48 hours of each other. The pleural fluid obtained via thoracentesis will be analyzed using Light's criteria, which will serve as the reference standard to evaluate the diagnostic accuracy of the ultrasound.
Diagnostic Accuracy of Chest Ultrasound Measured by Area Under the Curve (AUC)
The overall diagnostic accuracy of chest ultrasound in differentiating exudative from transudative pleural effusions will be evaluated by calculating the Area Under the Receiver Operating Characteristic Curve (AUC). Sonographic features (such as echogenicity and septations) will be assessed and validated against the biochemical reference standard (Light's criteria) obtained from pleural fluid analysis via thoracentesis.
Time frame: Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)
No study locations are listed for this record.
Start is estimated for May 2026; primary completion for May 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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