Malignant Pleural Effusion, Exudative Pleural Effusion
Conditions
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.
Interventions
PROCEDUREultrasound-guided pleural biopsy
Using ultrasound the optimal point of entry for thoracentesis is located. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site . Again, the area is wiped with disinfectant and a millimeter small skin incision is made with a pointed scalpel. Six US-guided biopsies of 1.2 millimetres using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core needle 18G, Temple, Arizona, USA). ) are taken from the parietal pleura. Thoracentesis is performed as described above using the same incision as the pleural biopsy.
PROCEDUREThoracentesis
The optimal point of entry (the largest distance between parietal and visceral pleura) is identified using ultrasound. This is usually on the lower, dorsal side of the chest. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site. The area is wiped with disinfectant and a millimeter skin incision is made with a pointed scalpel. A 7 French (or up to 16 French, to the choice of the clinician) pigtail catheter is inserted and connected to sealed bag. Fluid is aspirated via a 3-way valve, and transferred to relevant bottles for culture, analysis of albumin and LDH, protein, and for cytology.
Sponsors
Naestved Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of 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 |
| Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture. | 26 weeks post randomization | — |
| 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 |
| 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 |
| 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 |
| 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 | — |
| Patient reported discomfort and health | Day 1within 30 minutes after the end of procedure and 7 days post-procedure | measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version). |
Countries
Denmark
Outcome results
None listed