Clinical trial NCT04233359: A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.
Official title: Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pleural Effusion, Malignant
Pleural Effusion
Pleura; Exudate
Keywords: Pleural effusion
Malignant Pleural effusion
Pleura diagnostics
US-guided pleural biopsy
Local anesthetic thoracoscopy
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis
timeFrame: 26 weeks
measure: 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.
timeFrame: 26 weeks
Secondary outcomes:
measure: Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry.
timeFrame: 26 weeks
measure: Incidence of completed procedures
timeFrame: 1 week
measure: Time from randomization to conclusive, treatment-guiding diagnoses
timeFrame: 26 weeks
measure: Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure
timeFrame: Day of procedure/intervention
measure: Time from procedure start to patient leaving the procedure room and leaving the recovery room
timeFrame: Day of procedure/intervention
measure: Adverse event; complication to procedure: mortality
timeFrame: 30 days.
measure: Adverse event; complication to procedure: pneumothorax
timeFrame: 30 days.
measure: Adverse event; complication to procedure: haemoptysis
timeFrame: 30 days.
measure: Adverse event; complication to procedure: infection
timeFrame: 30 days.
measure: Adverse event; complication to procedure: hospital admission
timeFrame: 30 days.
measure: Total volume of pleural fluid removed
timeFrame: Day of procedure
measure: Patient reported discomfort reported via ESAS
timeFrame: Day of procedure pre- and post-procedure and 1 week followup
measure: Patient reported discomfort reported via EQ-5D-5L
timeFrame: Day of procedure pre- and post-proceudre and 1 week followup
measure: Willingness to repeat procedure
timeFrame: After procedure performed - within 30 minutes and 1 week after proceudre
measure: Cough
timeFrame: Pre-procedure, 1 week post procedure.
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Hospital
city: Roskilde
country: Denmark
facility: University Hospital Zealand, Roskilde
Study officials:
affiliation: Næstved
name: Uffe Bødtger, MD ph.d.
role: STUDY_CHAIR
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