Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Pleural Effusion
- Sponsor
- Naestved Hospital
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
Time Frame: 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 Outcomes
- Mean volume pleural fluid drained during thoracentesis(Day 1 within 30 minutes after the end of procedure)
- 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)
- 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)
- Patient reported cough(Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure)
- Pain during procedure(Day 1(within 30 minutes after the end of procedure))
- Change in patient reported discomfort(Day 1 within 30 minutes after the end of procedure)
- Willingness to repeat the procedure(day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure)
- Changes in patient reported discomfort and health(7 days post-procedure)
- Number of thoracenteses in these 7 days besides the study procedure.(7 days post-procedure)