Clinical trial · Interventional
Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura
Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
NCT04236037CI-TRIAL-00047340terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exudative Pleural Effusion | — | UNRESOLVED | — |
| Malignant Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracentesis | Procedure | — | UNRESOLVED |
| ultrasound-guided pleural biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ultrasound-guided thoracentesis
- description
- Ultrasound guided thoracentesis
- interventionNames
- Procedure: Thoracentesis
- type
- EXPERIMENTAL
- label
- Ultrasound-guided pleural biopsy and thoracentesis
- description
- 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
- interventionNames
- Procedure: ultrasound-guided pleural biopsy
- Procedure: Thoracentesis
Primary outcomes (1)
- measure
- Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDLight 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. PMID 4642731