Pre-EDIT: A Randomized Feasibility Trial of Elastance-Directed Intrapleural Catheter or Talc Pleurodesis in Malignant Pleural Effusion

Abstract

Talc slurry pleurodesis (TSP) prevents recurrence of symptomatic malignant pleural effusion (MPE) in 71%to 78%patients. Nonexpansile lung (NEL) frequently accounts for TSP failure but is often occult predrainage, impairing selection of patients. NEL is associated with high pleural elastance (PEL), but technical limitations have hampered the development of PEL as a predictive NEL marker. We performed a single-center, randomized, controlled, open-label feasibility trial of EDIT (elastance-directed indwelling pleural catheter or TSP) management, using a novel digital manometer and a new definition of high PEL. Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved PEL assessment during large-volume thoracentesis; patients with high PEL (maximum PEL sustained over 250mL [MaxPEL250]≥ 14.5cm H2O/L) were allocated to immediately receive an indwelling pleural catheter; the remainder underwent immediate drain placement for TSP. The primary outcome measure was recruitment feasibility, defined a priori as 30 patients over 12months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high PEL. The accuracy of the PEL definition for NEL was analyzed post hoc. Thirty-one patients were randomized (one allocation failure) over 12months. PEL assessment (mean duration, 33 minutes) was successful in 13 of 15 patients (87%). No directly attributable serious adverse events occurred. High PEL was detected in seven of 13 patients (54%), associated with 100%sensitivity and 67%specificity for NEL, and was first detected at a median volume of 325mL (range, 250-800mL). A phase 3 trial testing the effect of EDIT management on symptomatic MPE recurrence following TSP is feasible. ClinicalTrials.gov; No.: NCT03319186; URL: www.clinicaltrials.gov.