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| Name | Class |
|---|---|
| Rocket Medical plc | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDIT Management | Experimental |
| |
| Standard Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDIT Management | Procedure | EDIT management
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate of the manometry procedure | Defined as the proportion of patients in whom PEL cannot be computed | 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanne McGarry | Contact | + 44 141 232 1818 | joanne.mcgarry@ggc.scot.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth University Hospital | Recruiting | Glasgow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31374208 | Derived | 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. | |
| 29862030 | Derived |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015505 | Chest Tubes |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| Chest drain and talc pleurodesis | Procedure | Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines |
|
| 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). | 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) | 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:
| 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:
| 12 months |
| Martin 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. |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |