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EDIT Management Feasibility Trial (Pre-EDIT)

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ClinicalTrials.gov Identifier: NCT03319186
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Rocket Medical plc
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief 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 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.


Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Procedure: EDIT Management Procedure: Chest drain and talc pleurodesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: EDIT Management Procedure: EDIT Management

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.

Active Comparator: Standard Care Procedure: Chest drain and talc pleurodesis
Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Failure rate of the manometry procedure [ Time Frame: 12 months ]
    Defined as the proportion of patients in whom PEL cannot be computed

  2. Incidence of adverse events associated with the manometry procedure [ Time Frame: 12 months ]
    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

  3. Aspiration threshold to detect abnormal pleural elastance [ Time Frame: 12 months ]
    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).

  4. Proportion of patients requiring pneumothorax induction following manometry [ Time Frame: 12 months ]
    The proportion of patients in which pneumothorax induction is required to facilitate safe intercostal chest drain/IPC insertion in the EDIT arm (Group A)

  5. Assess accuracy of pleural cavity volume change assumptions [ Time Frame: 12 months ]

    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

  6. Assess accuracy of ultrasound effusion volume estimate [ Time Frame: 12 months ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:

    1. Pleural effusion with histocytologically proven pleural malignancy OR
    2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
    3. 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

Exclusion Criteria:

  • 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:

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319186


Contacts
Contact: Joanne McGarry + 44 141 232 1818 joanne.mcgarry@ggc.scot.nhs.uk

Locations
United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Contact: Kevin Blyth, MD       kevin.blyth@ggc.scot.nhs.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Rocket Medical plc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03319186     History of Changes
Other Study ID Numbers: GN17ON084
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms