Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer

The present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables. Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring temporary clamping of the renal artery rendering the kidney to a critical period of warm ischemia which is potentially harmful to the renal function. Image guided ablative modalities has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence within this domain is considered to be low as the existing literature is highly influenced by selection bias, and as of yet no randomized trial has compared the two modalities. Especially with the increasing age of the patients, an approach suitable for local anaestesia is desirable. Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to enter into a randomized trial to be treated with either RPN og CA. The study's primary endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint includes recurrence free survival 1, 3 and 5 years after treatment, readmission and complication rates as well as health economic evaluations. All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT thorax and glomerular filtration rate measurements.

Sex

All

Minimum age

18 Years

Maximum age

99 Years

Inclusion Criteria:

* First-time biopsy confirmed RCC
* ECOG Performance Status between 0 and 2
* The tumour is found to be eligible for both RPN and CA
* e-GFR\> 60 ml/min/1.74 m2
* Written consent after oral and written information has been given

Exclusion Criteria:

* Impaired renal function (e-GFR \<59 ml/min/1.74m2)
* Previously diagnosed with RCC
* Patients with recognized genetic mutations that directly relate to RCC (eg. Von Hippel Lindau, BHD)
* Allergy to contrast agents
* Pregnancy
* Expected remaining life \<12 months
* Active treatment of secondary cancer disease

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