EDIT Management Feasibility Trial (Pre-EDIT)

October 22, 2017 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Care
Procedure: Chest drain and talc pleurodesis
Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate of the manometry procedure
Time Frame: 12 months
Defined as the proportion of patients in whom PEL cannot be computed
12 months
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
12 months
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).
12 months
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)
12 months
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Rocket Medical plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2017

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

October 22, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 22, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN17ON084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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