Pleural EffusionNCT07513909
Evaluation of Transthoracic Ultrasonography in Differentiating Pleural Effusions
An observational study of Pleural Effusion and Transudative Pleural Effusion, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Transudative Pleural Effusion, Exudative Pleural Effusion
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult patients aged ≥18 years of either sex
- Clinically and radiologically documented pleural effusion (confirmed by chest X-ray and/or thoracic ultrasound)
- Patients scheduled for diagnostic or therapeutic thoracentesis as part of their standard clinical care
- Ability to provide written informed consent
Who cannot join
- Patients with a history of prior pleural interventions, including chemical or surgical pleurodesis or previous chest tube insertion on the affected side
- Patients with absolute contraindications to thoracentesis (e.g., uncorrectable coagulopathy, uncooperative patients, or hemodynamic instability)
- Poor transthoracic ultrasound window preventing adequate evaluation of the pleural space (e.g., due to severe obesity, extensive subcutaneous emphysema, or chest wall deformities)
- Patients with traumatic hemothorax.
About this study
Official title: Evaluation of Transthoracic Ultrasonography in Differentiating Exudative From Transudative Pleural Effusions
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.
Read the detailed description
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:
- Participants will undergo a full medical history assessment (evaluating symptoms, duration, and underlying comorbidities) and a physical examination.
- Baseline blood investigations will be drawn, including complete blood count (CBC), liver and kidney function tests, serum albumin, serum LDH, serum total protein, serum glucose and C-reactive protein (CRP).
- Chest Ultrasound (TUS):
- Imaging will be performed using a high-resolution B-mode ultrasound machine equipped with a convex low-frequency probe (3.5-5 MHz) for deep assessment and a linear high-frequency probe (7.5-12 MHz) for near-field evaluation.
- Patients will be examined in a sitting or semi-recumbent position.
- Evaluated sonographic parameters include the echogenicity of the pleural fluid (anechoic, homogenously echogenic, complex non-septated, complex septated, hyperechoic), the presence and number of septations, pleural thickening, surface irregularity, and fluid volume estimation.
- Reference Standard (Thoracentesis):
- Diagnostic thoracentesis will be performed under ultrasound guidance using a standard aseptic technique.
- Pleural fluid will be analyzed for total protein, LDH, glucose, albumin, and cell count (with additional microbiology or cytology if clinically indicated).
- Simultaneous serum protein, LDH, and albumin will be drawn within 2 hours of the procedure.
- The effusion will be officially classified as an exudate or transudate based on Light's criteria.
- Keywords
- Chest Ultrasound, Computed Tomography, Transudate, Exudate, Light's Criteria, Thoracentesis
- Medical subject headings
- Pleural Effusion, Hydrothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pleural Effusion Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Anwar Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513909
- Sponsor's protocol ID
- US in Pleural Effusions
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transthoracic Ultrasonography in Differentiating Exudative From Transudative Pleural Effusions
- ClinicalTrials.gov ID
- NCT07513909
- Acronym / sponsor ID
- US in Pleural Effusions
- Keywords
- Chest Ultrasound, Computed Tomography, Transudate, Exudate, Light's Criteria, Thoracentesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Participants will undergo a full medical history assessment (evaluating symptoms, duration, and underlying comorbidities) and a physical examination.
- Baseline blood investigations will be drawn, including complete blood count (CBC), liver and kidney function tests, serum albumin, serum LDH, serum total protein, serum glucose and C-reactive protein (CRP).
- Chest Ultrasound (TUS):
- Imaging will be performed using a high-resolution B-mode ultrasound machine equipped with a convex low-frequency probe (3.5-5 MHz) for deep assessment and a linear high-frequency probe (7.5-12 MHz) for near-field evaluation.
- Patients will be examined in a sitting or semi-recumbent position.
- Evaluated sonographic parameters include the echogenicity of the pleural fluid (anechoic, homogenously echogenic, complex non-septated, complex septated, hyperechoic), the presence and number of septations, pleural thickening, surface irregularity, and fluid volume estimation.
- Reference Standard (Thoracentesis):
- Diagnostic thoracentesis will be performed under ultrasound guidance using a standard aseptic technique.
- Pleural fluid will be analyzed for total protein, LDH, glucose, albumin, and cell count (with additional microbiology or cytology if clinically indicated).
- Simultaneous serum protein, LDH, and albumin will be drawn within 2 hours of the procedure.
- The effusion will be officially classified as an exudate or transudate based on Light's criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pleural Effusion Cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Adult patients aged ≥18 years of either sex
- Clinically and radiologically documented pleural effusion (confirmed by chest X-ray and/or thoracic ultrasound)
- Patients scheduled for diagnostic or therapeutic thoracentesis as part of their standard clinical care
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Patients with a history of prior pleural interventions, including chemical or surgical pleurodesis or previous chest tube insertion on the affected side
- Patients with absolute contraindications to thoracentesis (e.g., uncorrectable coagulopathy, uncooperative patients, or hemodynamic instability)
- Poor transthoracic ultrasound window preventing adequate evaluation of the pleural space (e.g., due to severe obesity, extensive subcutaneous emphysema, or chest wall deformities)
- Patients with traumatic hemothorax.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Chest Ultrasound Measured by Area Under the Curve (AUC)
Time frame: Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Transudative Pleural Effusion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Chest Ultrasound Measured by Area Under the Curve (AUC) (time frame: Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.