Withdrawn before it began
Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer
NCT03390413 · Jørgen Bjerggaard Jensen · Updated 1 June 2023
- What is being tested
- Robot; Cryoablation
- For
- Renal Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 99 years. The full rules are on the registry page.
- Where
- Denmark
- When
- Starts or started 1 Sept 2019, ends 1 March 2028. Registered 4 Jan 2018.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Aarhus University HospitalAarhus, Denmark
