Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura
- Conditions
- Malignant Pleural EffusionExudative Pleural Effusion
- Interventions
- Procedure: ThoracentesisProcedure: ultrasound-guided pleural biopsy
- Registration Number
- NCT04236037
- Lead Sponsor
- Naestved Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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.
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound-guided thoracentesis Thoracentesis Ultrasound guided thoracentesis Ultrasound-guided pleural biopsy and thoracentesis Thoracentesis Ultrasound-guided biopsy of the parietal pleura is taken through the same incision as the optimal site for thoracentesis and immediately prior to ultrasound-guided thoracentesis Ultrasound-guided pleural biopsy and thoracentesis ultrasound-guided pleural biopsy Ultrasound-guided biopsy of the parietal pleura is taken through the same incision as the optimal site for thoracentesis and immediately prior to ultrasound-guided thoracentesis
- Primary Outcome Measures
Name Time Method Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion. 26 weeks post randomization Our primary endpoint includes both patients who will receive palliative care and patients who will receive active treatment. For patients receiving palliative care, the presence of malignant cells is sufficient. However, for patients receiving active treatment, the primary endpoint is defined as a definite and treatment-guiding pathological result (immunohistochemistry, mutations, oncodrivers, culture and biochemistry) as decided by a multidisciplinary team conference.
- Secondary Outcome Measures
Name Time Method Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture. 26 weeks post randomization Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE. 26 weeks post randomization Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE. 26 weeks post randomization Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE. 26 weeks post randomization Proportion of true non-malignant PE at end of follow-up. 26 weeks post randomization Complications to pleural procedures Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure mortality, pneumothorax, haemoptysis, local bleeding, infections and hospital admissions
Mean volume pleural fluid drained during thoracentesis Day 1 within 30 minutes after the end of procedure measured in mL
The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE. 26 weeks post randomization Patient reported discomfort and health Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure Measured by Edmonton Symptom Assessment System (ESAS), scale 1-10, 0 being no symptoms, 10 being the worse symptoms
Patient reported cough Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure VAS score (visual analogue scale) for cough, 0-10, 0 being no cough, 10 being the worse cough
Pain during procedure Day 1(within 30 minutes after the end of procedure) Measured by VAS score (visual analogue scale) for pain, 0-10, 0 being no pain, 10 being the worse pain
Change in patient reported discomfort Day 1 within 30 minutes after the end of procedure iMeasured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough
Willingness to repeat the procedure day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure Measured by 5-point Likert scale,scale 1-5, 1 being definitely willing to have the procedure again, 5 being definitely not willing to have the procedure performed again
Changes in patient reported discomfort and health 7 days post-procedure Measured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough and health measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version).
Number of thoracenteses in these 7 days besides the study procedure. 7 days post-procedure
Trial Locations
- Locations (2)
Næstved Sygehus, department of pulmonary medicine
🇩🇰Næstved, Region Sjælland, Denmark
Zealand University Hospital, Roskilde, Department of Pulmonary medicine
🇩🇰Roskilde, Zealand, Denmark