A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.
- Conditions
- Pleural EffusionPleura; ExudatePleural Effusion, Malignant
- Registration Number
- NCT04233359
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis 26 weeks Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis
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. 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
Name Time Method Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry. 26 weeks Incidence of completed procedures 1 week Time from procedure start to patient leaving the procedure room and leaving the recovery room Day of procedure/intervention Adverse event; complication to procedure: pneumothorax 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
Patient reported discomfort reported via EQ-5D-5L Day of procedure pre- and post-proceudre and 1 week followup Denmark (Danish) © 2009 EuroQol Group EQ-5D™
Cough Pre-procedure, 1 week post procedure. Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough
Adverse event; complication to procedure: haemoptysis 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
Patient reported discomfort reported via ESAS Day of procedure pre- and post-procedure and 1 week followup ESAS - Edmonton Symptom Assesment System, Danish Version 2008
Time from randomization to conclusive, treatment-guiding diagnoses 26 weeks Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure Day of procedure/intervention Adverse event; complication to procedure: mortality 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
Adverse event; complication to procedure: infection 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
Adverse event; complication to procedure: hospital admission 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
Total volume of pleural fluid removed Day of procedure In mililiter (ml)
Willingness to repeat procedure 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
Trial Locations
- Locations (2)
Næstved Hospital
🇩🇰Næstved, Denmark
University Hospital Zealand, Roskilde
🇩🇰Roskilde, Denmark
Næstved Hospital🇩🇰Næstved, Denmark