Geoffrey A Martin1, Selina Tsim1, Andrew C Kidd2, John E Foster3, Philip McLoone4, Anthony Chalmers5, Kevin G Blyth6. 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.
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 (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. METHODS: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 250 mL [MaxPEL250] ≥ 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 PEL. The accuracy of the PEL definition for NEL was analyzed post hoc. RESULTS: Thirty-one patients were randomized (one allocation failure) over 12 months. 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 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.
RCT Entities:
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 (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. METHODS: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 250 mL [MaxPEL250] ≥ 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 PEL. The accuracy of the PEL definition for NEL was analyzed post hoc. RESULTS: Thirty-one patients were randomized (one allocation failure) over 12 months. 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 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.
Authors: Michael Lester; Fabien Maldonado; Otis B Rickman; Lance J Roller; Sameer K Avasarala; James M Katsis; Robert J Lentz Journal: BMJ Open Date: 2022-07-12 Impact factor: 3.006