Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
120 participants
INTERVENTIONAL
2015-05-31
2020-12-15
Brief Summary
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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.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Pleuroscopy
According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
Thoracoscopy
50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
VATS (thoracoscopy)
According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
VATS (thoracoscopy)
50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
Interventions
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Thoracoscopy
50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
VATS (thoracoscopy)
50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
Eligibility Criteria
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Inclusion Criteria
2. Indication for thoracoscopy according to BTS guidelines.
3. Patients accept further investigation according to Danish and BTS guidelines.
4. Have received oral and written consent and agreed.
5. At the time of inclusion, above 18 years of age.
Exclusion Criteria
2. Lack of language comprehension.
3. Legally incompetent patients.
4. Life expectancy less than 3 month.
5. Contraindications to pleural tissue sampling.
18 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Odense University Hospital
OTHER
Zealand University Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Bispebjerg Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Naestved Hospital
OTHER
Responsible Party
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Simon Reuter
Ph.d.-Student
Principal Investigators
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Uffe Boedtger, MD, PhD
Role: STUDY_DIRECTOR
Syddansk Universitet
Locations
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Naestved Hospital
Næstved, , Denmark
Countries
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Other Identifiers
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Resp-REPEAT-SIRE-2
Identifier Type: -
Identifier Source: org_study_id