Results of pre-EDIT; a randomised feasibility trial of Elastance-Directed Intra-pleural catheter or Talc Pleurodesis (EDIT) in malignant pleural effusion

Abstract

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 IPC (required in NEL) and TP (often effective if NEL absent; avoids prolonged drainage). 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: Consecutive patients with symptomatic MPE, no prior evidence of NEL or preference for IPC are randomised 1:1 between standard care (attempt at TP) and EDIT management (see Figure 1). The primary objective is to determine whether it is feasible to recruit and randomise 30 patients within 12 months (or 15 within 6 months). Secondary objectives include safety and refinement of the EDIT design, including validation of the current PEL definition using 4D volumetric Magnetic Resonance Imaging pre- and post-fluid aspiration. Results: Recruitment is on target (14/30 at time of submission) and will close on 28/8/18. Conclusion: Pre-EDIT will determine whether a multi-centre Phase III trial of EDIT management of MPE is feasible. Results will be ready for presentation at ERS Congress 2018.