Lung NeoplasmsREPEATNCT03272087
Rational Approach to a Unilateral Pleural Effusion
A study testing Thoracoscopy and VATS (thoracoscopy) in people with Lung Neoplasms, run by Naestved Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Thoracoscopy and VATS (thoracoscopy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Female patients: pregnancy or breastfeeding.
- Lack of language comprehension.
- Legally incompetent patients.
- Life expectancy less than 3 month.
- Contraindications to pleural tissue sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy
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.
Read more
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
- PET/CT is comparable to CT alone
- VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.
- Conditions
- Lung Neoplasms
- Being tested
- Thoracoscopy, VATS (thoracoscopy)
- Keywords
- Thoracoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracoscopyDevice
50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
VATS (thoracoscopy)Device
50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| Pleuroscopy | Active comparator | 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. Receives: Device: Thoracoscopy |
| VATS (thoracoscopy) | Active comparator | 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. Receives: Device: VATS (thoracoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (4)
Quality of life
Questionnaire developed to assess the quality of life of cancer patients, QLQC 30
Measured: 1 month
Total costs
calculated as costs patient-related, procedure-related, and overall
Measured: 2 years
Pain
VAS scale
Measured: 2 years
Quality of life
A standardised instrument for use as a measure of health outcome, EuroQol EQ-5D
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study startMay 2015
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Why it stopped: Patient inclusion cannot be completed within time limits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Zealand University Hospital, University Hospital, Gentofte, Copenhagen, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Simon Reuter, Naestved Hospital
- Investigators
- Uffe Boedtger, MD, PhD, Study director, Syddansk Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272087
- Sponsor's protocol ID
- Resp-REPEAT-SIRE-2
- Acronym
- REPEAT
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2015
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy
- ClinicalTrials.gov ID
- NCT03272087
- Acronym / sponsor ID
- REPEAT / Resp-REPEAT-SIRE-2
- Conditions
- Lung Neoplasms
- Keywords
- Thoracoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient inclusion cannot be completed within time limits
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Zealand University Hospital, University Hospital, Gentofte, Copenhagen, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- May 2015 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- PET/CT is comparable to CT alone
- VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleuroscopy | Active comparator | Device: ThoracoscopyAccording 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 comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Female patients: pregnancy or breastfeeding.
- Lack of language comprehension.
- Legally incompetent patients.
- Life expectancy less than 3 month.
- Contraindications to pleural tissue sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracoscopy50 % of patients will have performed af medical thoracoscopy (pleuroscopy) | Device | Pleuroscopy |
| VATS (thoracoscopy)50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy | Device | VATS (thoracoscopy) |
Primary outcome
Number of patients diagnosed with cancer
Time frame: 2 years
(cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).
4 secondary outcomes
Quality of life
Time frame: 1 month
Total costs
Time frame: 2 years
Pain
Time frame: 2 years
Quality of life
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Patient inclusion cannot be completed within time limits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uffe Boedtger, MD, PhD study director
Syddansk Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopy and VATS (thoracoscopy) in people with Lung Neoplasms, run by Naestved Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient inclusion cannot be completed within time limits). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed with cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.