Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies. Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions \>10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone. Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics. The investigators will perform two randomized studies to investigate whether 1. PET/CT is comparable to CT alone 2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
50% of patients with unilateral pleural effusion will have performed a CE-CT
50% of patients with unilateral pleural effusion will have performed a PET-CT
Naestved Sygehus
Næstved, Denmark
Number of diagnostic thoracoscopies (either MT or VATS)
Time frame: 2 years
Number of derived investigations (i.e. gastroscopy, coloscopy)
Time frame: 2 years
Number of patients diagnosed with cancer (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control)
Time frame: 2 years
Patient satisfaction and patient perceived discomfort
Using QLQC 30
Time frame: 2 years
Total costs calculated as costs patient-related, procedure-related, and overall
Time frame: 2 years
Total procedures before cancer-diagnosis (cancer = yes/no)
Time frame: 2 years
Patient satisfaction and patient perceived discomfort
EuroQol Q-5D a standardised instrument for use as a measure of health outcome
Time frame: 2 years
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