Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura

Naestved Hospital

Status: Terminated

Conditions: Exudative Pleural Effusion; Malignant Pleural Effusion

Treatments: Procedure: ultrasound-guided pleural biopsy; Procedure: Thoracentesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04236037

SJ-787

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Ultrasound-guided thoracentesis

Active Comparator group

Description:

Ultrasound guided thoracentesis

Treatment:

Procedure: Thoracentesis

Ultrasound-guided pleural biopsy and thoracentesis

Experimental group

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

Treatment:

Procedure: ultrasound-guided pleural biopsy

Procedure: Thoracentesis