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

Malignant Pleural Effusion Clinical Trial

Official title:

Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04236037
• Other study ID #: SJ-787
• Status: Terminated
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: September 23, 2020

Study information

• Verified date: September 2020
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exudative Pleural Effusion
• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Procedure:
• ultrasound-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.
• Thoracentesis
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.

Locations

Country	Name	City	State
Denmark	Næstved Sygehus, department of pulmonary medicine	Næstved	Region Sjælland
Denmark	Zealand University Hospital, Roskilde, Department of Pulmonary medicine	Roskilde	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Light 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.	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.	26 weeks post randomization
Secondary	Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture.		26 weeks post randomization
Secondary	Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE.		26 weeks post randomization
Secondary	Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE.		26 weeks post randomization
Secondary	Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE.		26 weeks post randomization
Secondary	The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE.		26 weeks post randomization
Secondary	Proportion of true non-malignant PE at end of follow-up.		26 weeks post randomization
Secondary	Complications to pleural procedures	mortality, pneumothorax, haemoptysis, local bleeding, infections and hospital admissions	Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure
Secondary	Mean volume pleural fluid drained during thoracentesis	measured in mL	Day 1 within 30 minutes after the end of procedure
Secondary	Patient reported discomfort and health	measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version).	Day 1within 30 minutes after the end of procedure and 7 days post-procedure
Secondary	Patient reported discomfort and health	Measured by Edmonton Symptom Assessment System (ESAS), scale 1-10, 0 being no symptoms, 10 being the worse symptoms	Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Secondary	Patient reported cough	VAS score (visual analogue scale) for cough, 0-10, 0 being no cough, 10 being the worse cough	Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Secondary	Pain during procedure	Measured by VAS score (visual analogue scale) for pain, 0-10, 0 being no pain, 10 being the worse pain	Day 1(within 30 minutes after the end of procedure)
Secondary	Willingness to repeat the 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	day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure
Secondary	Change in patient reported discomfort	iMeasured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough	Day 1 within 30 minutes after the end of procedure
Secondary	Changes in patient reported discomfort and health	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).	7 days post-procedure
Secondary	Number of thoracenteses in these 7 days besides the study procedure.		7 days post-procedure