Clinical trial NCT04236037: Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura
Official title: Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Pleural Effusion
Exudative Pleural Effusion
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.

Detailed description: Patients with unilateral pleural effusion with high protein content (exudative pleural effusion) are likely to have malignant pleural effusion. In the Danish guidelines, patient undergo two thoracentesis before more invasive procedures, due to the relatively low incidens of pleural TB and mesothelioma. The aim of the research group is to investigate the effect of early introduction of ultrasound-guided pleural biopsy taken at the optimal sport for thoracentesis. The research group will randomise half of our patients with unilateral pleural exudate to up-front ultrasound-guided biopsy and the other half usual care eg. a second thoracentesis, to see if there is a benefit of early pleural biopsy in the work-up of patients with unilateral pleural effusion, suspected of malignant pleural effusion.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Patients with a previous thoracentesis of a unilateral exudative pleural effusion according to Light's criteria (1) without malignant cells.
* CT thorax or PET-CT with contrast performed.
* Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT results or former cancer diagnosis.
* 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 with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
timeFrame: 26 weeks post randomization
Secondary outcomes:
measure: Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture.
timeFrame: 26 weeks post randomization
measure: Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE.
timeFrame: 26 weeks post randomization
measure: Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE.
timeFrame: 26 weeks post randomization
measure: Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE.
timeFrame: 26 weeks post randomization
measure: The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE.
timeFrame: 26 weeks post randomization
measure: Proportion of true non-malignant PE at end of follow-up.
timeFrame: 26 weeks post randomization
measure: Complications to pleural procedures
timeFrame: Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure
measure: Mean volume pleural fluid drained during thoracentesis
timeFrame: Day 1 within 30 minutes after the end of procedure
measure: Patient reported discomfort and health
timeFrame: Day 1within 30 minutes after the end of procedure and 7 days post-procedure
measure: Patient reported discomfort and health
timeFrame: Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
measure: Patient reported cough
timeFrame: Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
measure: Pain during procedure
timeFrame: Day 1(within 30 minutes after the end of procedure)
measure: Willingness to repeat the procedure
timeFrame: day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure
measure: Change in patient reported discomfort
timeFrame: Day 1 within 30 minutes after the end of procedure
measure: Changes in patient reported discomfort and health
timeFrame: 7 days post-procedure
measure: Number of thoracenteses in these 7 days besides the study procedure.
timeFrame: 7 days post-procedure
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Sygehus, department of pulmonary medicine
state: Region Sjælland
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde, Department of Pulmonary medicine
state: Zealand
Study officials:
affiliation: Department of Respiratory Medicine; Naestved Hospital, Denmark
name: Uffe Bødtger, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.