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Rational Approach to a Unilateral Pleural Effusion
REPEAT
Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy
1 other identifier
interventional
120
1 country
1
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedDecember 17, 2020
December 1, 2020
5.6 years
November 5, 2015
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Quality of life
1 month
Total costs
2 years
Pain
2 years
Quality of life
1 month
Study Arms (2)
Pleuroscopy
ACTIVE COMPARATORAccording 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)
ACTIVE COMPARATORAccording 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.
Interventions
50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Female patients: pregnancy or breastfeeding.
- Lack of language comprehension.
- Legally incompetent patients.
- Life expectancy less than 3 month.
- Contraindications to pleural tissue sampling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naestved Hospitallead
- University of Southern Denmarkcollaborator
- Odense University Hospitalcollaborator
- Zealand University Hospitalcollaborator
- University Hospital, Gentofte, Copenhagencollaborator
- Bispebjerg Hospitalcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (1)
Naestved Hospital
Næstved, 4700, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Uffe Boedtger, MD, PhD
Syddansk Universitet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.d.-Student
Study Record Dates
First Submitted
November 5, 2015
First Posted
September 5, 2017
Study Start
May 1, 2015
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12