Ample-3
Research type
Research Study
Full title
AMPLE-3: A Randomised Study Comparing Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis with Video-Assisted Thoracoscopic Surgery (VATS) for the Management of Patients with Malignant Pleural Effusion
IRAS ID
256935
Contact name
Owais Kadwani
Contact email
Sponsor organisation
Institute for Respiratory Health
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Pleurodesis is a procedure that seals up the space between the outer lining of your lung and chest wall (pleural cavity) to prevent fluid or air from continually building up around your lungs. Pleurodesis, the induction of pleural symphysis to seal the pleural space, is the most common therapy worldwide. Surgical pleurodesis (VATS) is video assisted pleurodesis; and is commonly regarded as the ‘definitive’ treatment, though this has never been supported by randomised control trials (RCTs). VATS is invasive and limited to fitter patients with longer prognoses. The alternative, for frailer patients, is chemical (talc slurry) pleurodesis via a chest tube.
Indwelling pleural catheter (IPC), an ambulatory drainage device, has been firmly established as an alternative therapy to talc slurry pleurodesis for MPE. Randomised studies have proven that IPC is significantly superior to talc slurry pleurodesis in reducing repeat pleural interventions and hospital days, without compromising on quality of life measures.
The Australasian Malignant PLeural Effusion (AMPLE) trial-3 is a multinational, multicentre Randomised controlled Trial, that addresses the outstanding question: is IPC superior to VATS pleurodesis in Mallignant Pleural Effusion (MPE) patients with no contraindication to surgery? MPE patients (n=160) with estimated survival >6 months will be randomised 1:1 to IPC or VATS.
Primary outcome is treatment failure (defined as requiring further pleural intervention) over 12 months or until death if sooner. Secondary outcomes include hospital days, Quality of Life (QoL) measures, physical activity levels, safety profile, health economics and survival.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0161
Date of REC Opinion
22 Jul 2022
REC opinion
Further Information Favourable Opinion