The PARTIAL study – a randomised trial of the clinical and cost effectiveness of PARTIAL vs radical nephrectomy for clinically localised renal cell carcinoma

RESEARCH QUESTION

Does partial nephrectomy (PN) for intermediate sized (stage T1b) & deep-seated small (T1a) tumours result in better outcomes than radical nephrectomy (RN) in patients with localised primary RCC & normal contralateral kidney? AIMS/OBJECTIVES Aim: Characterise the trade-off of the potential benefits, harms and costs over a 2-year follow-up in comparing PN & RN

1. Primary objectives: Describe benefits (renal function preservation) & harms (surgical complications)

2. Secondary objectives: Compare (i) HRQoL, (ii) cost & cost-effectiveness (capturing length of stay), (iii) quality of recovery, (iv) positive surgical margin rates (& retreatment), (v) survival (RFS/OS), (vi) cardiovascular events (inc. stroke), (vii) chronic kidney disease (CKD), (viii) operative conversions & (ix) patient acceptability

3. Long-term outcomes: (i) consent for separately funded follow-up allowing correlations of renal preservation with cardiovascular events, survival & end-stage kidney disease (ESKD) at 5–10-years. (ii) Establish a cohort of clinical data, urine, blood & tumour specimens for future studies (separately funded)

METHODS Design: Two-arm multicentre pragmatic superiority RCT (1:1) of PN vs RN Health technology: Minimal invasive surgery for both RN & PN (reflecting normal national practice) Target population (in 30 NHS secondary care sites):

1. Inclusion criteria: localised primary RCC on routine cross-sectional imaging, where the multidisciplinary team agrees both PN & RN are suitable, primariliy T1b (4-7cm) & selected T1a (