Malignant Pleural Effusion, Pleural Effusion, Ultrasound
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSystematic lung ultrasound
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.
Sponsors
Naestved Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion. | 26 weeks post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT | Day 1 within 30 minutes after the end of procedure | CT thorax and PET-CT (as assessed by radiologist or clinician at the initial planning of diagnostic work-up) |
| Proportion of cases where the change in the diagnostic process after LUS provide a diagnose | 26 weeks post procedure | Information found in electronic patient files. |
| The patient experienced pain during procedure score | Day 1 within 30 minutes after the end of procedure | Measured by a VAS (Visual Analogue Scale) scale 0-10, 0 being no pain, 10 being the worse pain |
| Characteristics of ultrasonic findings with additional systematic LUS. | Day 1, within 30 minutes after the end of procedure | Characteristics is recorded in the ultrasound protocol |
| The patients willingness to have the same examination again in the future if necessary | Day 1within 30 minutes after the end of procedure | 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 |
| Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis | Day 1 within 30 minutes after the end of procedure | Measured in minutes. |
| Patient experienced time consumption | Day 1 within 30 minutes after the end of procedure | Measured by a 3-point Likert scale , scale1-3, 1 being not time consuming at all, 3 being very time consuming |
Countries
Denmark
Outcome results
None listed