Pleural Effusion, MalignantPre-EDITNCT03319186
EDIT Management Feasibility Trial
A study testing EDIT Management and Chest drain and talc pleurodesis in people with Pleural Effusion, Malignant, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- EDIT Management and Chest drain and talc pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2017to Nov 2018
- 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
- Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:
- Pleural effusion with histocytologically proven pleural malignancy OR
- Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
- Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
- Degree of breathlessness for which therapeutic pleural intervention would be offered
- Age >18 years
- Expected survival > 3 months
- Written Informed Consent
Who cannot join
- Females who are pregnant or lactating
- Clinical suspicion of non-expansile lung for which talc pleurodesis would not be offered
- Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
- Previous ipsilateral failed talc pleurodesis
- Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
- Any contraindication to chest drain or IPC insertion, including:
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- Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC tunnel site
- Any contraindication to MRI scanning, including:
- Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign body Previously documented reaction to Gadolinium-containing intravenous contrast agent Significant renal impairment (eGFR<30 ml/min)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow
Kevin Blyth, MD, kevin.blyth@ggc.scot.nhs.uk
About this study
Official title: Pre-EDIT: A Randomised, Feasibility Trial of Elastance-Directed Intra-pleural Catheter or Talc Pleurodesis (EDIT) in the Management of Symptomatic Malignant Pleural Effusion Without Obvious Non-expansile Lung
Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as possible to minimise the amount of time they have to spend in hospital.
Standard treatment for MPE involves an admission to hospital to drain the fluid and then attempt to prevent the fluid from returning by sticking the lung to the inside of the rib cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but unfortunately it fails in about 30% of patients. This is usually because the lung has not fully re-expanded and has not made contact with the inside of the ribs. When this happens, the fluid can be effectively treated with a different type of drainage tube called an indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the district nurses.
It is thought that pressure measurements taken from the fluid as it is drained may be able to show doctors whether or not the lung will re-expand before patients are committed to either TP or an IPC. In this research we wish to test if these measurements can be used to choose which is the best first treatment option (TP or IPC) for patients with MPE. We have called this 'EDIT management'. Since it is uncertain whether this new approach will work, patients will be randomised to have either standard treatment or EDIT management. We will compare the two groups to assess whether the patients who had EDIT management had to have fewer repeat procedures over the following 3 months.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- EDIT Management, Chest drain and talc pleurodesis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDIT ManagementProcedure or surgery
EDIT management
- Volumetric Pleural MRI for pre-aspiration pleural cavity volume
- Large volume pleural aspiration with recording of intra-pleural pressure during aspiration
- Volumetric Pleural MRI for post-aspiration pleural cavity volume
- Computation of PEL250, defined as the rolling average of pleural elastance over the preceding 250ml aspirated. MaxPEL250 ≥ 14.5 cm H2O/L: allocated to 1st-line IPC MaxPEL250 < 14.5 cm H2O/L: allocated to 1st-line TP
- EDIT-directed 1st-line treatment to be delivered within 24 hours; if insufficient residual pleural fluid to allow standard Seldinger insertion technique then Boutin-type needle used for pneumothorax induction and guide wire insertion.
Chest drain and talc pleurodesisProcedure or surgery
Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines
| Study group | Role | What they receive |
|---|---|---|
| EDIT Management | Experimental | Not described Receives: Procedure: EDIT Management |
| Standard Care | Active comparator | Not described Receives: Procedure: Chest drain and talc pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care
The number of patients recruited and randomised within 12 months
Measured: 12 months
Secondary outcomes (6)
Failure rate of the manometry procedure
Defined as the proportion of patients in whom PEL cannot be computed
Measured: 12 months
Incidence of adverse events associated with the manometry procedure
Number of participants with Adverse Events (AEs) and Serious AEs (SAEs), defined by United Kingdom Good Clinical Practice in Research, associated with use of the digital pleural manometer
Measured: 12 months
Aspiration threshold to detect abnormal pleural elastance
The pleural fluid aspiration volume at which the rolling average pleural elastance over the preceding 250ml (PEL250) first exceeds the upper limit of normal (14.5cm H2O/L).
Measured: 12 months
Proportion of patients requiring pneumothorax induction following manometry
The proportion of patients in which pneumothorax induction is required to facilitate safe intercostal chest drain/IPC insertion in the EDIT arm (Group A)
Measured: 12 months
Assess accuracy of pleural cavity volume change assumptions
To test the assumption that pleural cavity volume change is equivalent to the volume of pleural fluid removed during aspiration by measuring:
- Pleural fluid aspiration volume
- Pleural cavity volume change, as measured directly using volumetric Magnetic Resonance Imaging (MRI), calculated as pre- minus post-aspiration pleural cavity volume
Measured: 12 months
Assess accuracy of ultrasound effusion volume estimate
To test the accuracy of a predictive model of pleural effusion volume based on thoracic ultrasound measurements by measuring:
- Thoracic ultrasound estimated total pleural effusion volume
- Pre-pleural fluid aspiration pleural cavity volume measured by volumetric MRI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start28 Aug 2017
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Rocket Medical plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319186
- Sponsor's protocol ID
- GN17ON084
- Acronym
- Pre-EDIT
- Status last verified
- Oct 2017
- First submitted
- 4 Aug 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin GA, Tsim S, Kidd AC, Foster JE, McLoone P, Chalmers A, Blyth KG. Pre-EDIT: A Randomized Feasibility Trial of Elastance-Directed Intrapleural Catheter or Talc Pleurodesis in Malignant Pleural Effusion. Chest. 2019 Dec;156(6):1204-1213. doi: 10.1016/j.chest.2019.07.010. Epub 2019 Jul 30.
PubMed 31374208Martin GA, Tsim S, Kidd AC, Foster JE, McLoone P, Chalmers A, Blyth KG. Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion. BMJ Open Respir Res. 2018 May 29;5(1):e000293. doi: 10.1136/bmjresp-2018-000293. eCollection 2018.
PubMed 29862030
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-EDIT: A Randomised, Feasibility Trial of Elastance-Directed Intra-pleural Catheter or Talc Pleurodesis (EDIT) in the Management of Symptomatic Malignant Pleural Effusion Without Obvious Non-expansile Lung
- ClinicalTrials.gov ID
- NCT03319186
- Acronym / sponsor ID
- Pre-EDIT / GN17ON084
- Conditions
- Pleural Effusion, Malignant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Rocket Medical plc
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 24 Oct 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.
Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as possible to minimise the amount of time they have to spend in hospital.
Standard treatment for MPE involves an admission to hospital to drain the fluid and then attempt to prevent the fluid from returning by sticking the lung to the inside of the rib cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but unfortunately it fails in about 30% of patients. This is usually because the lung has not fully re-expanded and has not made contact with the inside of the ribs. When this happens, the fluid can be effectively treated with a different type of drainage tube called an indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the district nurses.
It is thought that pressure measurements taken from the fluid as it is drained may be able to show doctors whether or not the lung will re-expand before patients are committed to either TP or an IPC. In this research we wish to test if these measurements can be used to choose which is the best first treatment option (TP or IPC) for patients with MPE. We have called this 'EDIT management'. Since it is uncertain whether this new approach will work, patients will be randomised to have either standard treatment or EDIT management. We will compare the two groups to assess whether the patients who had EDIT management had to have fewer repeat procedures over the following 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDIT Management | Experimental | Procedure: EDIT Management |
| Standard Care | Active comparator | Procedure: Chest drain and talc pleurodesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:
- Degree of breathlessness for which therapeutic pleural intervention would be offered
- Age >18 years
- Expected survival > 3 months
- Written Informed Consent
Key exclusion criteria (9 listed)
- Females who are pregnant or lactating
- Clinical suspicion of non-expansile lung for which talc pleurodesis would not be offered
- Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
- Previous ipsilateral failed talc pleurodesis
- Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
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 |
|---|---|---|
| EDIT ManagementEDIT management 1. Volumetric Pleural MRI for pre-aspiration pleural cavity volume 2. Large volume pleural aspiration with recording of intra-pleural pressure during aspiration 3. Volumetric Pleural MRI for post-aspiration pleural cavity volume 4. Computation of PEL250, defined as the rolling average of pleural elastance over the preceding 250ml aspirated. MaxPEL250 ≥ 14.5 cm H2O/L: allocated to 1st-line IPC MaxPEL250 < 14.5 cm H2O/L: allocated to 1st-line TP 5. EDIT-directed 1st-line treatment to be delivered within 24 hours; if insufficient residual pleural fluid to allow standard Seldinger insertion technique then Boutin-type needle used for pneumothorax induction and guide wire insertion. | Procedure or surgery | EDIT Management |
| Chest drain and talc pleurodesisIntercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines | Procedure or surgery | Standard Care |
Primary outcome
Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care
Time frame: 12 months
The number of patients recruited and randomised within 12 months
6 secondary outcomes
Failure rate of the manometry procedure
Time frame: 12 months
Incidence of adverse events associated with the manometry procedure
Time frame: 12 months
Aspiration threshold to detect abnormal pleural elastance
Time frame: 12 months
Proportion of patients requiring pneumothorax induction following manometry
Time frame: 12 months
Assess accuracy of pleural cavity volume change assumptions
Time frame: 12 months
Assess accuracy of ultrasound effusion volume estimate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 31374208Martin GA, Tsim S, Kidd AC, Foster JE, McLoone P, Chalmers A, Blyth KG. Pre-EDIT: A Randomized Feasibility Trial of Elastance-Directed Intrapleural Catheter or Talc Pleurodesis in Malignant Pleural Effusion. Chest. 2019 Dec;156(6):1204-1213. doi: 10.1016/j.chest.2019.07.010. Epub 2019 Jul 30.
- Derived from this study: PubMed 29862030Martin GA, Tsim S, Kidd AC, Foster JE, McLoone P, Chalmers A, Blyth KG. Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion. BMJ Open Respir Res. 2018 May 29;5(1):e000293. doi: 10.1136/bmjresp-2018-000293. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDIT Management and Chest drain and talc pleurodesis in people with Pleural Effusion, Malignant, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne McGarry (+ 44 141 232 1818, joanne.mcgarry@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319186, which also lists 2 linked publications.
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 24 Oct 2017.