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

Geoffrey A Martin; Selina Tsim; Andrew C Kidd; John E Foster; Philip McLoone; Anthony Chalmers; Kevin G Blyth

doi:10.1016/j.chest.2019.07.010

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

Chest. 2019 Dec;156(6):1204-1213. doi: 10.1016/j.chest.2019.07.010. Epub 2019 Jul 30.

Authors

Geoffrey A Martin¹, Selina Tsim¹, Andrew C Kidd², John E Foster³, Philip McLoone⁴, Anthony Chalmers⁵, Kevin G Blyth⁶

Affiliations

¹ Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.
² Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.
³ Glasgow Clinical Research Imaging Facility, Queen Elizabeth University Hospital, Glasgow, UK.
⁴ Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
⁵ Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Beatson West of Scotland Cancer Centre, Glasgow, UK.
⁶ Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. Electronic address: kevin.blyth@glasgow.ac.uk.

PMID: 31374208
DOI: 10.1016/j.chest.2019.07.010

Abstract

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_EL), but technical limitations have hampered the development of P_EL 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_EL.

Methods: Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved P_EL assessment during large-volume thoracentesis; patients with high P_EL (maximum P_EL sustained over 250 mL [MaxP_EL250] ≥ 14.5 cm 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 12 months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high P_EL. The accuracy of the P_EL definition for NEL was analyzed post hoc.

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

Keywords: elastance; malignant pleural effusion; nonexpansile lung; pleural manometry; trapped lung; unexpandable lung.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Catheterization / instrumentation
Catheterization / methods*
Catheters, Indwelling
Feasibility Studies
Female
Humans
Male
Middle Aged
Pleural Effusion, Malignant / therapy*
Pleurodesis / methods*
Prospective Studies
Respiratory Function Tests
Talc / therapeutic use*

Substances

Talc

Associated data

ClinicalTrials.gov/NCT03319186