Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion

Study Overview
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Brief Summary
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The value of lung ultrasound in the work up of pleural effusion (fluid in between the thin doublet layered film surrounding the lungs) is unknown. The researchers will perform a systematic lung ultrasound scan including a scan for extra thoracic metastasis (spread of cancer to other organs) in the lymphnodes of the neck and metastasis lever in 56 patients one-sided pleural effusion. The researchers will measure if the interventions change the diagnostic plan for the patient and leads to faster diagnostics of the underlying course.

Official Title
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Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study

Conditions
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Pleural Effusion, Malignant Pleural Effusion, Ultrasound

Intervention / Treatment
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* Diagnostic Test: Systematic lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Unilateral pleural effusion of unknown course. Patients must be able to give informed consent. Exclusion Criteria: Bilateral pleural effusions. Known cause of pleural effusions. Life expectancy <3 months. Inability to understand written or spoken Danish.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systematic lung ultrasound<br>Patients with unilateral pleural effusion of unknown course | Diagnostic Test: Systematic lung ultrasound<br>* Patients will undergo a systematic lung ultrasound including review of: Sonographic characteristic of effusion Parietal, diaphragmatic and visceral pleura Pleural nodules Lung parenchyma Extra pulmonary findings: Hepatic pathology, enlarged lymph nodes of the neck and a cardiac assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion. | Information found in electronic patient files. Comparison of diagnostics planned before systematic ultrasound and diagnostics planned after systematic ultrasound. Measured in proportion of included patients | 26 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of ultrasonic findings with additional systematic LUS. | Characteristics is recorded in the ultrasound protocol | Day 1, within 30 minutes after the end of procedure | 
| Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT | CT thorax and PET-CT (as assessed by radiologist or clinician at the initial planning of diagnostic work-up) | Day 1 within 30 minutes after the end of procedure | 
| Proportion of cases where the change in the diagnostic process after LUS provide a diagnose | Information found in electronic patient files. | 26 weeks post procedure | 
| The patient experienced pain during procedure score | Measured by a VAS (Visual Analogue Scale) scale 0-10, 0 being no pain, 10 being the worse pain | Day 1 within 30 minutes after the end of procedure | 
| Patient experienced time consumption | Measured by a 3-point Likert scale , scale1-3, 1 being not time consuming at all, 3 being very time consuming | Day 1 within 30 minutes after the end of procedure | 
| The patients willingness to have the same examination again in the future if necessary | Measured by a 5-point Likert scale, scale 1-5, 1 being definitely willing to have the examination again, 5 being definitely not willing to have the examination again | Day 1within 30 minutes after the end of procedure | 
| Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis | Measured in minutes. | Day 1 within 30 minutes after the end of procedure |