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

NCT04235998 | Completed DMC

• 1 other identifier: SJ-789
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion; Malignant Pleural Effusion; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Characteristics of ultrasonic findings with additional systematic LUS.

  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

  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

  26 weeks post procedure

• The patient experienced pain during procedure score

  Day 1 within 30 minutes after the end of procedure

• Patient experienced time consumption

  Day 1 within 30 minutes after the end of procedure

Study Arms (1)

Systematic lung ultrasound

Patients with unilateral pleural effusion of unknown course

Diagnostic Test: Systematic lung ultrasound

Interventions

Systematic lung ultrasound DIAGNOSTIC_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.

Systematic lung ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years.
• Unilateral pleural effusion of unknown course.
• Patients must be able to give informed consent.

You may not qualify if:

• Bilateral pleural effusions.
• Known cause of pleural effusions.
• Life expectancy \<3 months.
• Inability to understand written or spoken Danish.

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (1)

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

Location

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Uffe Bødtger, MD, PhD

  Department of Pulmonary Medicin, Næstved Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 22, 2020
• Study Start: February 17, 2020
• Primary Completion: November 20, 2020
• Study Completion: May 6, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)