Rational Approach to a Unilateral Pleural Effusion2 (REPEAT)
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|ClinicalTrials.gov Identifier: NCT02834455|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : August 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Device: Contrast-enhanced CT Device: PET-CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Active Comparator: CE-CT scanning
Contrast-enhanced CT scan of the thorax and abdomen.
Device: Contrast-enhanced CT
50% of patients with unilateral pleural effusion will have performed a CE-CT
Active Comparator: PET-CT scanning
Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen.
50% of patients with unilateral pleural effusion will have performed a PET-CT
- 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 [ Time Frame: 2 years ]Using QLQC 30
- 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 [ Time Frame: 2 years ]EuroQol Q-5D a standardised instrument for use as a measure of health outcome
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): NCT02834455
|Contact: Simon B Reuter, MDfirstname.lastname@example.org|
|Contact: Uffe Boedtger, MD, PhDemail@example.com|
|Naestved, Denmark, 4700|
|Contact: Simon Reuter, MD firstname.lastname@example.org|
|Principal Investigator: Simon B Reuter, MD|
|Study Director:||Uffe Boedtger, MD, PhDemail@example.com|