Clinical trial NCT04235998: Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion
Official title: Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Malignant Pleural Effusion
Ultrasound
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Pleura Clinic (an outpatient clinic in the Department of Pulmonary Disease, Næstved Sygehus, on of two regional centers for work up of pulmonary malignancy ) from the general practitioner or from other hospital departments both Næstved Sygehus and other hospitals.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.
timeFrame: 26 weeks post procedure
Secondary outcomes:
measure: Characteristics of ultrasonic findings with additional systematic LUS.
timeFrame: Day 1, within 30 minutes after the end of procedure
measure: Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT
timeFrame: Day 1 within 30 minutes after the end of procedure
measure: Proportion of cases where the change in the diagnostic process after LUS provide a diagnose
timeFrame: 26 weeks post procedure
measure: The patient experienced pain during procedure score
timeFrame: Day 1 within 30 minutes after the end of procedure
measure: Patient experienced time consumption
timeFrame: Day 1 within 30 minutes after the end of procedure
measure: The patients willingness to have the same examination again in the future if necessary
timeFrame: Day 1within 30 minutes after the end of procedure
measure: Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis
timeFrame: Day 1 within 30 minutes after the end of procedure
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Sygehus, department of pulmonary medicine
state: Region Sjælland
Study officials:
affiliation: Department of Pulmonary Medicin, Næstved Sygehus
name: Uffe Bødtger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: