Development and Evaluation of the EPIToME (Early Pleurodesis via IPC for Treatment of Malignant Effusion) Protocol

BACKGROUND: Malignant pleural effusion management often involves multiple procedures that are painful and have risks. Indwelling pleural catheters (IPC) are associated with reduced re-intervention rates. Recently published trials have focused on optimising IPC aftercare to improve pleurodesis rates, reduce complications and expedite catheter removal. We combined available data into one protocol and evaluated it in an unselected cohort. RESEARCH QUESTION: Is initial IPC insertion as first-line intervention for MPE (combined with talc instillation and daily drainage where suitable) safe, feasible and effective? METHODS: The EPIToME protocol was developed to minimize pleural interventions and was evaluated in a prospective, unselected cohort of MPE patients. RESULTS: The EPIToME protocol managed all symptomatic MPEs (unless contraindicated), with IPC insertion, inpatient talc instillation via the IPC, and daily ambulatory drainage if full lung expansion was achieved. Otherwise, symptom-guided drainage was performed. Of 102 MPE patients, 47 (46.1%) patients underwent talc instillation, of which 74.5% achieved pleurodesis after 20 (median, 95%CI=6.7-33.3) days. Those unsuitable for pleurodesis (55%) underwent symptom-guided drainage. Fifty-five patients had the IPC removed after fluid cessation. The EPIToME protocol required a hospital stay of two to three days, similar to standard pleurodesis. Complications (infection 11.8%, symptomatic loculation 10.8%) were within expected ranges, but interpretation of safety is limited in the absence of a comparator group. Only 3 patients (2.9%) required further pleural re-intervention post-IPC removal. INTERPRETATION: We developed and demonstrated the feasibility of the EPIToME approach which aims to minimize interventions for all-comers with MPE. Combining IPC, talc pleurodesis and daily drainage may be effective and should be evaluated in randomized trials.