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

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ClinicalTrials.gov Identifier: NCT04236037
Recruitment Status : Terminated (It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.)
First Posted : January 22, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Exudative Pleural Effusion Procedure: ultrasound-guided pleural biopsy Procedure: Thoracentesis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound

Arm Intervention/treatment
Active Comparator: Ultrasound-guided thoracentesis
Ultrasound guided thoracentesis
Procedure: 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.

Experimental: Ultrasound-guided pleural biopsy and thoracentesis
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
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.

Procedure: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture. [ Time Frame: 26 weeks post randomization ]
  2. Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE. [ Time Frame: 26 weeks post randomization ]
  3. Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE. [ Time Frame: 26 weeks post randomization ]
  4. Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE. [ Time Frame: 26 weeks post randomization ]
  5. The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE. [ Time Frame: 26 weeks post randomization ]
  6. Proportion of true non-malignant PE at end of follow-up. [ Time Frame: 26 weeks post randomization ]
  7. Complications to pleural procedures [ Time Frame: Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure ]
    mortality, pneumothorax, haemoptysis, local bleeding, infections and hospital admissions

  8. Mean volume pleural fluid drained during thoracentesis [ Time Frame: Day 1 within 30 minutes after the end of procedure ]
    measured in mL

  9. Patient reported discomfort and health [ Time Frame: Day 1within 30 minutes after the end of procedure and 7 days post-procedure ]
    measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version).

  10. Patient reported discomfort and health [ Time Frame: Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure ]
    Measured by Edmonton Symptom Assessment System (ESAS), scale 1-10, 0 being no symptoms, 10 being the worse symptoms

  11. Patient reported cough [ Time Frame: Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure ]
    VAS score (visual analogue scale) for cough, 0-10, 0 being no cough, 10 being the worse cough

  12. Pain during procedure [ Time Frame: Day 1(within 30 minutes after the end of procedure) ]
    Measured by VAS score (visual analogue scale) for pain, 0-10, 0 being no pain, 10 being the worse pain

  13. Willingness to repeat the procedure [ Time Frame: day og procedure (within 30 minutes after the end of procedure) and 1 week post-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

  14. Change in patient reported discomfort [ Time Frame: Day 1 within 30 minutes after the end of procedure ]
    iMeasured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough

  15. Changes in patient reported discomfort and health [ Time Frame: 7 days post-procedure ]
    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).

  16. Number of thoracenteses in these 7 days besides the study procedure. [ Time Frame: 7 days post-procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236037


Locations
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Denmark
Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland, Denmark, 4700
Zealand University Hospital, Roskilde, Department of Pulmonary medicine
Roskilde, Zealand, Denmark, 4000
Sponsors and Collaborators
Naestved Hospital
Investigators
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Principal Investigator: Uffe Bødtger, MD, PhD, Department of Respiratory Medicine; Naestved Hospital, Denmark
Publications:
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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT04236037    
Other Study ID Numbers: SJ-787
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms