None listed
Conditions
Brief summary
This study will compare the effect of two different indwelling pleural catheter (IPC) drainage strategies on breathlessness and quality of life in patients with a malignant pleural effusion (MPE). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a symptomatic malignant pleural effusion (MPE) for which drainage is considered appropriate by the managing clinician. Study details All participants in this study will be eligible if they need to have an indwelling Pleural Catheter (IPC) inserted for the management of their malignant pleural effusion. IPC allow fewer invasive procedures and reduced hospitalizations than conventional talc pleurodesis. Participants will then be randomly allocated (by chance) to one of two groups. Participants in one group will be asked to drain their effusions every day for the first 60 days (unless certain criteria are met). For participants in the other group, drainage will only be performed if the patient feels that the effusion-related symptoms (usually breathlessness, cough and/or tightness) have recurred. All participants will be asked to complete regular questionnaires for up to 1 year in order to rate their level of breathlessness and quality of life. Other clinical outcomes, any adverse events, and health care utilisation will also be monitored throughout the study. We hope to determine which regime is superior in improving clinical outcomes so that management of cancer patients with an MPE can be optimised.
Interventions
All patients who require IPC placement for management of a MPE will be identified by the PI of each study site or his/her team. Screening criteria are based on standard clinical practice and consecutive eligible patients will be offered trial entry. The principal investigator or a nominated member of staff will approach participants who fulfil the criteria to enter the trial. Screening logs will be kept.
The inclusion and exclusion criteria are in keeping with those employed in large RCTs of MPE
All patients who require IPC placement for management of a MPE will be identified by the PI of each study site or his/her team. Screening criteria are based on standard clinical practice and consecutive eligible patients will be offered trial entry. The principal investigator or a nominated member of staff will approach participants who fulfil the criteria to enter the trial. Screening logs will be kept. The inclusion and exclusion criteria are in keeping with those employed in large RCTs of MPE. Trial treatments- interventional and control Participants will be randomly assigned (1:1) to either one of two IPC drainage strategies: i) The Aggressive Drainage arm: Patients will drain their effusions every day for the first 60 days unless - clinically contraindicated - if spontaneous pleurodesis occurred. This is defined as less than 50mL of fluid removed on three consecutive drainages, in the absence of any significant residual pleural fluid collections on imaging. Participants will be taught how to drain their own IPCs at home with the either the help of a family member or friend or have access to community nursing support systems. Drainage will take up to 30 minutes. The IPC will remain in situ until either spontaneous pleurodesis or death.
Sponsors
Prof YC Gary Lee
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a symptomatic MPE in whom fluid drainage is considered appropriate by the managing clinician. A MPE is defined as one in which malignant cells are identified in the pleural fluid or pleural biopsy; or a large exudative pleural effusion without other causes in a patient with known disseminated extra-thoracic malignancy.
Exclusion criteria
Age <18 yrs; expected survival <3 months; pleural infection; chylothorax; pregnancy or lactation; un-correctable bleeding diathesis; previous ipsilateral lobectomy/pneumonectomy; significant loculations likely to preclude effective fluid drainage; significant visual impairment and inability to consent or comply with the protocol.
Outcome results
None listed