Kidney cancer Cancer Renal cancer
Conditions
Interventions
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): Invo
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate, measured using number of participants recruited per month during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Retention rate, measured using randomised participants retained and assessed with valid primary outcome data, measured annually 2. Health-related quality of life measured using EQ5D-5L prior to treatment and 3 months following treatment 3. Complications, blood transfusion, ITU admission and renal replacement requirement rates, measured using clinical records during hospital admission, 30 days post-operative and at 6 months 4. Length of hospital stay, time to return to pre-treatment activities, number of work days lost (in those who work), measured using clinical records and follow-up consultation (clinic or telephone) at 30 days and at 6 months 5. Costs incurred by health technologies, measured using NHS reference costs and also private and societal costs measured using patient completed questionnaire at time of treatment, at 30 days and at 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed