EDIT Management Feasibility Trial

NCT03319186 | Unknown

• 1 other identifier: GN17ON084
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Failure rate of the manometry procedure

  12 months

• Incidence of adverse events associated with the manometry procedure

  12 months

• Aspiration threshold to detect abnormal pleural elastance

  12 months

• Proportion of patients requiring pneumothorax induction following manometry

  12 months

• Assess accuracy of pleural cavity volume change assumptions

  12 months

Study Arms (2)

EDIT Management

EXPERIMENTAL

Procedure: EDIT Management

Standard Care

ACTIVE COMPARATOR

Procedure: Chest drain and talc pleurodesis

Interventions

EDIT Management PROCEDURE

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.

EDIT Management

Chest drain and talc pleurodesis PROCEDURE

Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Rocket Medical plc: collaborator

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 31374208 DERIVED

• 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.

  PMID: 29862030 DERIVED

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Central Study Contacts

Joanne McGarry

CONTACT

+ 44 141 232 1818; joanne.mcgarry@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: October 24, 2017
• Study Start: August 28, 2017
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)