Pleural EffusionNCT04235998
Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion
An observational study of Pleural Effusion and Malignant Pleural Effusion, run by Naestved Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant Pleural Effusion, Ultrasound
- What is being tested?
- Systematic lung ultrasound
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Feb 2020to 6 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years.
- Unilateral pleural effusion of unknown course.
- Patients must be able to give informed consent.
Who cannot join
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland, 4700
About this study
Official title: Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study
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.
- Conditions
- Pleural Effusion, Malignant Pleural Effusion, Ultrasound
- Being tested
- Systematic lung ultrasound
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic lung ultrasoundDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Systematic lung ultrasound | Patients with unilateral pleural effusion of unknown course Receives: Diagnostic Test: Systematic lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks post procedure
Secondary outcomes (7)
Characteristics of ultrasonic findings with additional systematic LUS.
Characteristics is recorded in the ultrasound protocol
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 within 30 minutes after the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start17 Feb 2020
- Primary completion20 Nov 2020
- Study completion6 May 2021
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.
- 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
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uffe Bødtger, MD, PhD, Principal investigator, Department of Pulmonary Medicin, Næstved Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235998
- Sponsor's protocol ID
- SJ-789
- Status last verified
- May 2022
- First submitted
- 19 Dec 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04235998
- Acronym / sponsor ID
- SJ-789
- Conditions
- Pleural Effusion, Malignant Pleural Effusion, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 22 Jan 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systematic lung ultrasound | – | Diagnostic Test: Systematic lung ultrasoundPatients with unilateral pleural effusion of unknown course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Unilateral pleural effusion of unknown course.
- Patients must be able to give informed consent.
Key exclusion criteria (4 listed)
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic lung ultrasoundPatients 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. | Diagnostic test | Systematic lung ultrasound |
Primary outcome
Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.
Time frame: 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
7 secondary outcomes
Characteristics of ultrasonic findings with additional systematic LUS.
Time frame: 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
Time frame: 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
Time frame: 26 weeks post procedure
The patient experienced pain during procedure score
Time frame: Day 1 within 30 minutes after the end of procedure
Patient experienced time consumption
Time frame: Day 1 within 30 minutes after the end of procedure
The patients willingness to have the same examination again in the future if necessary
Time frame: Day 1within 30 minutes after the end of procedure
Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis
Time frame: Day 1 within 30 minutes after the end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Uffe Bødtger, MD, PhD principal investigator
Department of Pulmonary Medicin, Næstved Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Malignant Pleural Effusion, run by Naestved Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion. (time frame: 26 weeks post procedure). 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 11 May 2022.