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A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233359
Recruitment Status : Terminated (To few patients recruited to allow for study completion within ph.d. project.)
First Posted : January 18, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Brief Summary:

Pleural fluid can be caused by cancer. Patients with repeated presentation of pleural fluid where initial diagnostic tests have been inconclusive are the focus of this trial. In this clinical trial patients are randomized into two groups and the efficacy of local anesthetic thoracoscopy (LAT) is compared to an ultrasound guided biopsy of the outer lining of the lung. The aim is not only the diagnostic yield in diagnosing cancer, but also the procedures ability to diagnose specific cancer mutations and immune system markings.

Methods and objectives:

Patients with reoccuring one-sided pleural fluid, with a marked clinical risk of cancer based on findings in medical work-up, radiological scans, biochemistry and medical history and who are undiagnosed upon initial pleural fluid analysis are the target patients of the trial. Patients are randomized into two groups to have undertaken either pleural biopsy at the optimal site for a repeat thoracentesis or LAT. Thus diagnostic yield for both fluid analysis and biopsy analysis will be compared to tissue samples taken with LAT.

We hypothesize that LAT is superior both to pleural biopsy and repeat thoracentesis in providing diagnostic clarification and providing sufficient basis for treatment without further procedures resulting in less time consumption, cost and discomfort for the patient.


Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Pleural Effusion Pleura; Exudate Procedure: Local anesthetic thoracoscopy Procedure: US-guided pleural biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study
Actual Study Start Date : December 20, 2019
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: US-guided pleural biopsy and thoracentesis

Pleural biopsy:

Using ultrasound the optimal point of entry for thoracentesis is located, and local anesthesia is obtained. The area is wiped with disinfectant and a skin incision is made with a pointed scalpel. Six US-guided biopsies of 1x2 millimetres are taken from the parietal pleura using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core Biopsy Needle 18G, Tempe, Arizona, USA). Afterward, a thoracentesis is performed in the same incision as used by the pleural biopsy. A pigtail catheter is inserted and fastened and connected to a sealed bag and fluid is aspirated and sent to relevant analysis.

Procedure: US-guided pleural biopsy
In local anesthesia, a closed needle biopsy is performed Ultrasound guided of the parietal pleura at the place of deepest fluid recess in the intrathoracic space. A pigtail catheter French 7-16 is placed afterwards for fluid drainage.

Experimental: LAT and thoracentesis
Local anesthetic thoracoscopy: Pre-procedure a pleural pigtail catheter is inserted and pleural fluid is removed. The catheters one-way valve is opened and the patient takes several breaths thereby creating a pneumothorax prior to procedure start. The patient is sedated with midazolam and morphine. Midaxillary access through intercostal space 4-7 is achieved in local anesthesia and via a skin incision a trocar is placed for access to the thoracic space. A semi-rigid thoracoscope (model LTF 160; Olympus, Tokyo, Japan) is inserted via the trocar and the pleural cavity is inspected after removal of residual effusion whereof at least 40ml is sent to cytology. Pleural parietal biopsies are taken under direct visual guidance. The recommended number of biopsies is 10-15. If no abnormalities were seen, random biopsies are taken. After relevant biopsies are taken the instruments are removed the pigtail catheter stays inserted to allow for removal of air and expansion of the lung.
Procedure: Local anesthetic thoracoscopy
Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
Other Name: medical thoracoscopy




Primary Outcome Measures :
  1. Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis [ Time Frame: 26 weeks ]
    Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis

  2. Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate. Local anesthetic thoracoscopy vs US-guided pleural biopsy. [ Time Frame: 26 weeks ]
    Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis


Secondary Outcome Measures :
  1. Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry. [ Time Frame: 26 weeks ]
  2. Incidence of completed procedures [ Time Frame: 1 week ]
  3. Time from randomization to conclusive, treatment-guiding diagnoses [ Time Frame: 26 weeks ]
  4. Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure [ Time Frame: Day of procedure/intervention ]
  5. Time from procedure start to patient leaving the procedure room and leaving the recovery room [ Time Frame: Day of procedure/intervention ]
  6. Adverse event; complication to procedure: mortality [ Time Frame: 30 days. ]
    Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system

  7. Adverse event; complication to procedure: pneumothorax [ Time Frame: 30 days. ]
    Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system

  8. Adverse event; complication to procedure: haemoptysis [ Time Frame: 30 days. ]
    Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system

  9. Adverse event; complication to procedure: infection [ Time Frame: 30 days. ]
    Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system

  10. Adverse event; complication to procedure: hospital admission [ Time Frame: 30 days. ]
    Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system

  11. Total volume of pleural fluid removed [ Time Frame: Day of procedure ]
    In mililiter (ml)

  12. Patient reported discomfort reported via ESAS [ Time Frame: Day of procedure pre- and post-procedure and 1 week followup ]
    ESAS - Edmonton Symptom Assesment System, Danish Version 2008

  13. Patient reported discomfort reported via EQ-5D-5L [ Time Frame: Day of procedure pre- and post-proceudre and 1 week followup ]
    Denmark (Danish) © 2009 EuroQol Group EQ-5D™

  14. Willingness to repeat procedure [ Time Frame: After procedure performed - within 30 minutes and 1 week after proceudre ]
    5 Point Likert Scale, 1 not likely to repeat, 5 most likely to repeat

  15. Cough [ Time Frame: Pre-procedure, 1 week post procedure. ]
    Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough



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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 or older patients with single previous thoracentesis of a unilateral pleural exudate according to Lights criteria without malignant cells.
  • Lights Criteria:

Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the Laboratorys normal Serum LDH

  • Contrast enhanced CT of the Chest and abdomen performed
  • Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia
  • Pet-CT results or former cancer diagnosis Informed consent

Exclusion Criteria:

  • bilateral pleural effusions
  • known cause of pleural effusion
  • likely non-malignant course of a unilateral pleura effusion such as (but not restricted to) pneumonia, trauma, pleuritis, heart failure
  • any contraindication to the study procedures

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): NCT04233359


Locations
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Denmark
Næstved Hospital
Næstved, Denmark, 4700
University Hospital Zealand, Roskilde
Roskilde, Denmark, 4000
Sponsors and Collaborators
Naestved Hospital
Investigators
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Study Chair: Uffe Bødtger, MD ph.d. Næstved
Publications:

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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT04233359    
Other Study ID Numbers: SJ-790
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: September 28, 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
Keywords provided by Naestved Hospital:
Pleural effusion
Malignant Pleural effusion
Pleura diagnostics
US-guided pleural biopsy
Local anesthetic thoracoscopy
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
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents