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

Background: 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 (P), but technical limitations have hampered the development of P 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 P.

Methods: Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved P assessment during large-volume thoracentesis; patients with high P (maximum P sustained over 250 mL [MaxP] ≥ 14.5 cm HO/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 12 months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high P. The accuracy of the P definition for NEL was analyzed post hoc.

Results: Thirty-one patients were randomized (one allocation failure) over 12 months. P assessment (mean duration, 33 minutes) was successful in 13 of 15 patients (87%). No directly attributable serious adverse events occurred. High P 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 325 mL (range, 250-800 mL).

Conclusions: A phase 3 trial testing the effect of EDIT management on symptomatic MPE recurrence following TSP is feasible.

Trial Registry: ClinicalTrials.gov; No.: NCT03319186; URL: www.clinicaltrials.gov.