Pleural EffusionEXPLORENCT02463955
Exploration of the Pleural Cavity Using a fleXible endoscoPe
A study testing flexible video endoscope and video-rigid thoracoscope in people with Pleural Effusion, run by University Hospital, Rouen.
Trial summary
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- flexible video endoscope and video-rigid thoracoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2016
- 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
- Diagnosis of pleural effusion affirmed by chest radiography,
- Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
- Inpatient or outpatient,
- Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
- For postmenopausal women, menopause confirmation of diagnosis,
Who cannot join
- Pleural effusion compression,
- Pleural effusion infected or suspected of infection,
- Febrile patient (> 38 ° C)
- Parapneumonic effusion
- Immunosuppression (eg, neutropenia <1G / L, immunosuppressive therapy, ...)
- Portage known multidrug-resistant germ or S. aureus resistant to methicillin,
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- Clinical suspicion of tuberculosis,
- Patients who have already been treated by pleurodesis,
- Contraindication to general anesthesia,
- Contraindication of prophylactic antibiotics,
- Contraindication to pleurodesis agent
- Increased bleeding risk,
- No one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
- Pregnant or breastfeeding women.
About this study
Official title: Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
Read the detailed description
Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
- Conditions
- Pleural Effusion
- Being tested
- flexible video endoscope, video-rigid thoracoscope
- Keywords
- flexible endoscopy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible video endoscopeDevice
Thoracoscopy is done using flexible video endoscope
video-rigid thoracoscopeDevice
Thoracoscopy is done using video-rigid thoracoscope
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopy | Experimental | 1. experimental intervention (flexible video endoscope)
2. reference procedure (video-rigid thoracoscope) Receives: Device: flexible video endoscope; Device: video-rigid thoracoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of the pleural cavity exploration using the flexible endoscope
Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.
Measured: at 0 hours
Secondary outcomes (8)
Outcome of a complication
Complications are defined by any of the following: any grade >2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Measured: at 0 hours
Outcome of a complication
Complications are defined by any of the following: any grade >2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Measured: at 4 hours
Outcome of a complication
Complications are defined by any of the following: any grade >2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Measured: Day 7
Outcome of a complication
Complications are defined by any of the following: any grade >2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Measured: 1 month
Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
Measured: Day -7 : 7 days before the intervention
Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
Measured: at 0 hours
Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation
Two independent experts will visualize the video-recordings of the intervention and evaluate tee completeness of the exploration using a standardized score.
Measured: at 0 hours
Diagnostic yield of biopsies performed with the flexible endoscope
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJul 2016
Why it stopped: study never start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BASTE Jean Marc, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463955
- Sponsor's protocol ID
- 2014/182/HP
- Other IDs
- 2014-A01660-47
- Acronym
- EXPLORE
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
- ClinicalTrials.gov ID
- NCT02463955
- Acronym / sponsor ID
- EXPLORE / 2014/182/HP
- Conditions
- Pleural Effusion
- Keywords
- flexible endoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
Detailed description
Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopy | Experimental | Device: flexible video endoscope, Device: video-rigid thoracoscope1. experimental intervention (flexible video endoscope) 2. reference procedure (video-rigid thoracoscope) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of pleural effusion affirmed by chest radiography,
- Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
- Inpatient or outpatient,
- Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
- For postmenopausal women, menopause confirmation of diagnosis,
Key exclusion criteria (14 listed)
- Pleural effusion compression,
- Pleural effusion infected or suspected of infection,
- Febrile patient (> 38 ° C)
- Parapneumonic effusion
- Immunosuppression (eg, neutropenia <1G / L, immunosuppressive therapy, ...)
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 |
|---|---|---|
| flexible video endoscopeThoracoscopy is done using flexible video endoscope | Device | Thoracoscopy |
| video-rigid thoracoscopeThoracoscopy is done using video-rigid thoracoscope | Device | Thoracoscopy |
Primary outcome
Completeness of the pleural cavity exploration using the flexible endoscope
Time frame: at 0 hours
Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.
8 secondary outcomes
Outcome of a complication
Time frame: at 0 hours
Outcome of a complication
Time frame: at 4 hours
Outcome of a complication
Time frame: Day 7
Outcome of a complication
Time frame: 1 month
Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
Time frame: Day -7 : 7 days before the intervention
Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
Time frame: at 0 hours
Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation
Time frame: at 0 hours
Diagnostic yield of biopsies performed with the flexible endoscope
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
BASTE Jean Marc, MD principal investigator
University Hospital, Rouen
Questions about this trial
What is this clinical trial studying?
A study testing flexible video endoscope and video-rigid thoracoscope in people with Pleural Effusion, run by University Hospital, Rouen.
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 14 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: withdrawn, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Completeness of the pleural cavity exploration using the flexible endoscope (time frame: at 0 hours). 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 Aug 2016.