Renal cancer Cancer
Conditions
Interventions
Potential participants will be identified through hospital urologist clinics and screening in local and regional specialist multi-disciplinary teams. Adults with suspected or confirmed clinically loca
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults >=18 years 2. Newly diagnosed clinically localised renal cancer (suspected on cross-sectional imaging or histologically confirmed) 3. Local multi-disciplinary review identifying those cases thought to be suitable for both minimally invasive RN or PN; (for minimally invasive we mean laparoscopic or robotic surgery; cases where open surgery is planned are not eligible) 4. Cross-sectional imaging showing a single tumour, stage T1 (up to 7cm), where there is equipoise in the MDT and willingness to recruit into the trial 5. On imaging, evidence of a radiologically normal contralateral kidney 6. Patients that have been fully counselled of all the available treatment options (including non-surgical approaches, where appropriate) 7. Able and willing to give informed consent to participate and to participate in study procedures
Exclusion criteria
Exclusion criteria: 1. Solitary functioning kidney 2. Metastatic disease 3. Existing Chronic Kidney Disease (> stage 3b; eGFR< 45) 4. Medically unfit for surgery 5. Congenital renal abnormality which includes fusion, assent and malrotation 6. Suspected or confirmed inherited kidney cancer syndrome 7. Current pregnancy or breastfeeding 8. People without capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Renal function preservation by estimated glomerular filtration rate (eGFR) measured using a blood test and standard procedures at baseline, 1 week and 1 month after surgery and 6, 12 and 24 months after randomisation 2. Surgical complications measured using the Comprehensive Complications Index (CCI) to 3 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life (HRQoL) measured using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and the 36-Item Short Form Health Survey (SF-36) acute version (1-week recall) participant questionnaires at baseline, 1 week, 1 month and 3 months after surgery and 3, 6, 12, 18 and 24 months after randomisation 2. Cost-effectiveness (quality-adjusted life-year and costs) measured using case note reviews and participant questionnaires at baseline, surgery, 1 week, 1 month and 3 months after surgery and 3, 6, 12, 18 and 24 months after randomisation 3. Quality of recovery capturing length of stay measured using the 15-item Quality of Recovery-15 (QoR-15) scale participant questionnaire at 1 week, 1 month and 3 months after surgery 4. Rates of positive surgical margin rates and retreatment / surgical revision measured by case note review (pathology report) at surgery and 24 months after randomisation 5. Recurrence-free and overall survival including local recurrence measured by case note review at 24 months after randomisation 6. Cardiovascular events (non-fatal heart attack, non-fatal stroke and cardiovascular death) measured by case note review at 24 months after randomisation 7. Progression to chronic kidney disease stages 3, 4, and 5 (added 04/03/2024: including end-stage renal failure) by estimated glomerular filtration rate (eGFR) measured using a blood test and standard procedures at baseline, 1 week and 1 month after surgery and 6, 12 and 24 months after randomisation 7. Operative conversion to radical nephrectomy measured by case note review at surgery 8. Patient acceptability measured using interviews in embedded mixed methods trial process evaluation and participant questionnaire at 3 months after surgery | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactDiana Johnson
Outcome results
None listed