Rational Approach to a Unilateral Pleural Effusion2

Study Overview
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Brief Summary
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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 PET/CT is comparable to CT alone VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

Official Title
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Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: Contrast-enhanced CT
* Device: PET-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines. Indication for thoracoscopy according to BTS guidelines. Patients accept further investigation according to Danish and BTS guidelines. Have received oral and written consent and agreed. At the time of inclusion, above 18 years of age. Exclusion Criteria: Female patients: pregnancy or breastfeeding. Lack of language comprehension. Legally incompetent patients. Life expectancy less than 3 month. Contraindications to pleural tissue sampling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CE-CT scanning<br>Contrast-enhanced CT scan of the thorax and abdomen. | Device: Contrast-enhanced CT<br>* 50% of patients with unilateral pleural effusion will have performed a CE-CT<br>|
| Active Comparator: PET-CT scanning<br>Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen. | Device: PET-CT<br>* 50% of patients with unilateral pleural effusion will have performed a PET-CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diagnostic thoracoscopies (either MT or VATS) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of derived investigations (i.e. gastroscopy, coloscopy) |  | 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) |  | 2 years | 
| Patient satisfaction and patient perceived discomfort | Using QLQC 30 | 2 years | 
| Total costs calculated as costs patient-related, procedure-related, and overall |  | 2 years | 
| Total procedures before cancer-diagnosis (cancer = yes/no) |  | 2 years | 
| Patient satisfaction and patient perceived discomfort | EuroQol Q-5D a standardised instrument for use as a measure of health outcome | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopy