An interventional study of EDIT Management and Chest drain and talc pleurodesis in Pleural Effusion, Malignant, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-24.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
Among 16 studies in Pleural Effusion, Malignant with a site in United Kingdom — 2 open to participants now, 2 under way, none of them phase 3. Pleural Effusion, Malignant · United Kingdom.
Among the 16 studies in Pleural Effusion, Malignant with a site in United Kingdom, this one is the 9th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2017, is one of 6 with no phase, and was the 10th registered.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
Browse Pleural Effusion, Malignant studies →2 of the 16 studies in Pleural Effusion, Malignant with a site in United Kingdom are open now. Recruiting first, the newest first:
Cambridge University Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 18+
University of Oxford · Sites in United Kingdom
Ages 18+ · Healthy volunteers
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 25 Pleural Effusion, Malignant studies recruiting now, 15 (60%) set no upper age limit and 5 (20%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2
First in 2003; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.
Median enrollment 119 across the 11 interventional studies, 18 across the 5 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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4 of 16 have an industry lead sponsor. The 10 most frequent:
NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
NHS Greater Glasgow and Clyde has 2 studies filed under Pleural Effusion, Malignant — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Pleural Effusion, Malignant with a site in United Kingdom, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:
Exclusion Criteria:
Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC tunnel site
Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign body Previously documented reaction to Gadolinium-containing intravenous contrast agent Significant renal impairment (\<30 ml/min)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: EDIT Management
Procedure: Chest drain and talc pleurodesis
EDIT 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.
Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines
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
Time frame: 12 months
Failure rate of the manometry procedure
Defined as the proportion of patients in whom PEL cannot be computed
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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: 1. Pleural fluid aspiration volume 2. Pleural cavity volume change, as measured directly using volumetric Magnetic Resonance Imaging (MRI), calculated as pre- minus post-aspiration pleural cavity volume
Time frame: 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: 1. Thoracic ultrasound estimated total pleural effusion volume 2. Pre-pleural fluid aspiration pleural cavity volume measured by volumetric MRI
Time frame: 12 months
Plan to share: No
Started Aug 2017 (actual). Primary completion is estimated for Aug 2018, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde →