Abstract
BACKGROUND: Localised renal cell carcinoma is treated with radical nephrectomy (RN) or partial nephrectomy (PN). Nephron-sparing PN increases preservation of renal function, reducing incidence of end stage renal failure and associated cardiovascular events. In patients with exophytic T1a (≤ 4 cm) tumours and normal contralateral kidney, PN is standard of care. In patients with T1b (> 4-7 cm) or endophytic T1a tumours and normal contralateral kidney, the benefits of PN over RN are less clear as there are increased surgical complications and more tissue may be excised reducing the preservation of renal function. There are no high-quality studies to address if PN is superior to RN in these more complex cases.
METHODS: PARTIAL is a pragmatic randomised controlled parallel group unblinded superiority trial with embedded internal pilot and economic and process evaluation. A total of 420 participants will be recruited in UK NHS centres with expertise in minimally invasive nephrectomy techniques. Eligible consenting adults with a single T1 renal cell carcinoma, normal contralateral kidney and equipoise within the multidisciplinary team confirming suitability to receive both interventions by minimally invasive approaches are randomised 1:1 to PN or RN. Patients with metastatic disease, existing chronic kidney disease, solitary functioning kidney, congenital renal abnormality, inherited kidney cancer syndrome, who lack capacity to consent or are pregnant or breast feeding are excluded. Primary outcomes are gains in preservation of renal function at 2 years and surgical complications over the peri-operative period. Secondary outcomes are quality of life and recovery, cost and cost-effectiveness, rates of positive surgical margin, recurrence and cardiovascular events, overall survival, progression to chronic kidney disease and end stage renal failure, operative conversion and patient acceptability. Participants are followed up for 2 years with outcomes collected from medical records and participant questionnaires.
DISCUSSION: PARTIAL will determine if gains from PN are superior to RN and offset the potential harms and costs in complex T1 renal tumours suitable for either approach. If PN is not found to provide clinically significant gains and excess complications are confirmed, then a practice-changing case for RN as standard of care could be made.
TRIAL REGISTRATION: ISRCTN 11293415. Registered prospectively on 19 January 2023.
| Original language | English |
|---|---|
| Article number | 331 |
| Number of pages | 53 |
| Journal | Trials |
| Volume | 27 |
| Issue number | 1 |
| Early online date | 20 Mar 2026 |
| DOIs | |
| Publication status | Published - 29 Apr 2026 |
Data Availability Statement
The final trial dataset will be accessible to the trial statistician and health economist for the purpose of trial analysis. The final trial dataset may also be made available on reasonable request. A request to access the final trial datasets generated during the trial should be directed in the first instance to the chief investigator (Professor Naeem Soomro; [email protected]; and copied to [email protected]). The datasets collected in questionnaires at all timepoints, transcripts of process evaluation interviews, and the baseline, surgery, discharge and pathology, 3 month (CCI), eGFR follow-up, 24 month and serious adverse event case report forms for all participants recruited to the trial will be available. The dataset will be available in fully anonymised electronic form, at an individual level and in accordance with participant consent. The data dictionaries, trial protocol, statistical analysis plan, health economics plan, patient information leaflet and template case report forms will be available on request to facilitate interpretation of data. Questionnaire templates, or parts thereof, may be available pending review of the relevant licensing agreements. Electronic data for the trial will be available within a local repository at the University of Aberdeen and will be retained for a period of at least 5 years after close of trial in accordance with funder, sponsor and local archiving procedures. Applicants will require to complete a data request form that will be reviewed by a Data Sharing Committee, which includes the chief investigator. Applications will be considered on a case-by-case basis from bonafide researchers. We are obligated to ensure that optimal use is made of the data that are collected for research and we recognise the value of sharing individual-level data. The interests of research participants, researchers and other stakeholders will be considered when considering each application. A fully authorised data sharing agreement will be required prior to the release of data.Funding
The trial is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (NIHR133561). The views expressed are those of the authors and not necessarily those of the NIHR or Department of Health and Social Care. The funder was not involved in the design of the trial, the collection, analysis and interpretation of data, or in writing of this manuscript.
| Funders | Funder number |
|---|---|
| National Institute for Health and Care Research | NIHR133561 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
-
SDG 3 Good Health and Well-being
Keywords
- Kidney cancer
- nephron-sparing surgery
- radical nephrectomy
- renal cell carcinoma
- renal function
- Humans
- Pragmatic Clinical Trials as Topic
- Treatment Outcome
- Randomized Controlled Trials as Topic
- Carcinoma, Renal Cell/surgery
- Multicenter Studies as Topic
- Nephrectomy/methods
- Cost-Benefit Analysis
- Quality of Life
- Kidney Neoplasms/surgery
- Equivalence Trials as Topic
Fingerprint
Dive into the research topics of 'PARTIAL: study protocol for a clinical and cost-effectiveness of complex PARTIAL vs radical nephrectomy for clinically localised renal cell carcinoma randomised trial'. Together they form a unique fingerprint.Cite this
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS