Introduction Non-expansile lung (NEL) is a common cause of talc pleurodesis (TP) failure in malignant pleural effusion (MPE), but is often occult prior to drainage. Reliable detection of NEL would allow patients to be allocated between intrapleural catheter (IPC) and TP. High pleural elastance (PEL) has been associated with NEL in observational studies. Pre-EDIT is a randomised feasibility trial of elastance-directed IPC or TP (EDIT) management using a novel, purpose-built digital pleural manometer (Rocket Medical, UK).
Methods and analysis Consecutive patients with MPE without prior evidence of NEL or preference for IPC will be randomised 1:1 between EDIT management and standard care (an attempt at TP). The primary objective is to determine whether sufficient numbers of patients (defined as 30 within 12 months (or 15 over 6 months)) can be recruited and randomised to justify a subsequent phase III trial testing the efficacy of EDIT management. Secondary objectives include safety, technical feasibility and validation of study design elements, including the definition of PEL using 4D pleural MRI before and after fluid aspiration. EDIT involves PEL assessment during a large volume pleural fluid aspiration, followed by an attempt at TP or placement of an IPC within 24 hours. Patients will be allocated to IPC if the rolling average PEL sustained over at least 250 mL fluid aspirated (PEL250) is ≥ 14.5 cm H2O/L.
Ethics and dissemination Pre-EDIT was approved by the West of Scotland Regional Ethics Committee on 8 March 2017 (Ref: 17/WS/0042). Results will be presented at scientific meetings and published in peer-reviewed journals.
Trial registration number NCT03319186; Pre-results.
- pleural disease
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Statistics from Altmetric.com
Contributors GAM: contribution to the conception and design of the work, data acquisition, analysis and interpretation of data for the work; drafting the work. GAM, ST, ACK, JEF, PM, AC, KGB: final approval of the version to be published; agrees to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. ST: contribution to the conception and design of the work and interpretation of data for the work. ST, ACK, JEF, PM, AC, KGB: revising the work critically for important intellectual content; final approval of the version to be published. ACK: contribution to the design of the work and data acquisition for the work. JEF: contribution to the design of the work, data acquisition, analysis, and interpretation of data for the work. PM: contribution to the design of the work, analysis and interpretation of data for the work. AC: contribution to the design of the work. KGB: principal contribution to the conception and design of the work; data acquisition, analysis and interpretation of data for the work
Funding This work was supported by Rocket Medical (UK) and the West of Scotland Lung Cancer Research Group (Award September 2015). KGB is part-funded by NHS Research Scotland.
Competing interests Rocket Medical (UK) have part-funded this work and will supply the digital pleural manometry equipment to be used in the study.
Patient consent Not required.
Ethics approval Pre-EDIT was approved by the West of Scotland Regional Ethics Committee on 8 March 2017 (Ref: 17/WS/0042).
Provenance and peer review Not commissioned; externally peer reviewed.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.