A feasibility study of a cohort embedded randomised controlled trial comparing NEphron-Sparing Treatment (NEST) for small renal masses
Kidney cancer
Randomisation will be performed in blocks of 10 participants through the online system 'Sealed Envelope' (www.sealedenvelope.com) to ensure allocation concealment. 1. Cryotherapy (intervention): Involves the freezing of the tumour by using percutaneous needles. 2. Robot-assisted partial nephrectomy (standard care): involves surgery to remove the tumour and leave the rest of the kidney behind. Follow-up for the purposes of this feasibility trial will be 6 months, but standard clinical follow up will be at least 5 years.
Inclusion criteria for study cohort: 1. Informed consent 2. Males and females 3. > 18 years of age 4. Diagnosed with renal mass <4 cm in size Inclusion criteria for randomisation/interventional cohort: 1. Biopsy proven RCC 2. Tumours that are suitable for robot-assisted PN and CO
Exclusion criteria for study cohort: 1. Any of the above listed inclusion criteria not met 2. Patient unable to provide or indicate informed consent Exclusion criteria for randomisation/interventional cohort: Patients with any concurrent medical/surgical condition or indication, which would mean the SMDT recommends one treatment modality is more suitable than another, such as: 1. Myocardial Infarction in preceding 6/12 2. Pulmonary disease not allowing for prolonged anaesthesia 3. Multiple previous abdominal surgery/interventions, making surgical approach high risk 4. Performance status > = 2 5. Metastatic disease 6. Charlson co-morbidity index > 3 7. Patients with multifocal tumours 8. Patients with suspected or diagnosed with inherited kidney cancer susceptibility syndromes 9. Women that are pregnant or breastfeeding