OPTIMUM: a protocol for a multicentre randomised controlled trial comparing Out Patient Talc slurry via Indwelling pleural catheter for Malignant pleural effusion vs Usual inpatient Management

Abstract

IntroductionThe development of malignant pleural effusion (MPE) results in disabling breathlessness, pain and reduced physical capability with treatment a palliative strategy. Ambulatory management of MPE has the potential to improve quality of life (QoL). The OPTIMUM trial is designed to determine whether full outpatient management of MPE with an indwelling pleural catheter (IPC) and pleurodesis improves QoL compared with traditional inpatient care with a chest drain and talc pleurodesis. OPTIMUM is currently open for any centres interested in collaborating in this study.Methods and analysisOPTIMUM is a multicentre non-blinded randomised controlled trial. Patients with a diagnosis of MPE will be identified and screened for eligibility. Consenting participants will be randomised 1:1 either to an outpatient ambulatory pathway using IPCs and talc pleurodesis or standard inpatient treatment with chest drain and talc pleurodesis as per British Thoracic Society guidelines. The primary outcome measure is global health-related QoL at 30 days measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures include breathlessness and pain measured using a 100 mm Visual Analogue Scale and health-related QoL at 60 and 90 days. A sample size of 142 patients is needed to demonstrate a clinically significant difference of 8 points in global health status at 30 days, for an 80% power and a 5% significance level.Ethics and disseminationThe study has been approved by the NRES Committee South East Coast—Brighton and Sussex (reference 15/LO/1018). The trial results will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numbersUKCRN19615 and ISRCTN15503522; Pre-results.

Expanding knowledge on non‐expandable lungs

“…The EPIToME approach circumvents our inability to accurately predict/define NEL, and decreases unnecessary pleural interventions. The OPTIMUM (Out Patient Talc slurry via Indwelling pleural catheter for Malignant pleural effusion vs Usual inpatient Management) study is a multicentre RCT employing a similar (IPC followed by talc slurry via the catheter) protocol and comparing this with conventional bedside talc pleurodesis with small‐bore chest tubes in improving the quality‐of‐life of MPE patients. These studies will have impact on future research priorities in NEL.…”

Pleurodesis

“…We await the results OPTIMUM and IPC-PLUS trials, which evaluated outpatient IPC with TS pleurodesis versus TS pleurodesis only. 117,118 In addition, the role of IPC in nonmalignant effusion has yet to be clearly delineated and more data are awaited from the REDUCE trial (ISRCTN66354436). • Further improving our ability to predict successful pleurodesis.…”

Talkumpleurodese über dauerhaft implantierten Katheter bei malignem Pleuraerguss

“…Darüber hinaus scheint die Pleurodese-Rate (43%) niedriger als bei der Pleurodese via Thoraxdrainage, die etwa 70% beträgt. Ein Vergleich einer Pleurodese via IPC gegenüber einer Thoraxdrainage ist aktuell Gegenstand einer klinischen Studie [3]. Die symptomatische Besserung, die durch einen IPC (ohne Pleurodese) erreicht werden kann, scheint hingegen vergleichbar mit einer Pleurodese via Thoraxdrainge [2,4].…”