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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04236037
Other study ID # SJ-787
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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