Looking for volunteers
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
NCT06536439 · University Hospital, Ghent · Updated 1 April 2025
- What is being tested
- Pre-operative explanation of the procedure (DIPLANN + CT); Pre-operative surgical planning (DIPLANN + CT); RAPN (DIPLANN + CT); Pre-operative explanation of the procedure (CT only); Pre-operative surgical planning (CT only); RAPN (CT only)
- For
- Kidney Cancer; Kidney Neoplasms; Kidney Diseases; Renal Cancer; Renal Cell Carcinoma; Renal Disease
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 235 people. The full rules are on the registry page.
- Where
- Belgium (5 sites)
- When
- Starts or started 27 June 2024, ends 1 Jan 2027. Registered 5 Aug 2024.
- Results
- None posted yet.
In the researchers' words
A proposed new tool ('DIPLANN-tool' - Digital Planning in Nephrectomy) for predicting kidney perfusion zones on a segmented 3D model during robot-assisted partial nephrectomy (RAPN) for localized renal cancer demonstrated high accuracy when planning selective clamping (SC) for RAPN. However, the tool's clinical added value still needs to be confirmed. Therefore, a randomized controlled trial using a study and control group is the preferred study design. Experimental group: the use of the DIPLANN-tool + conventional computed tomography (CT) imaging for preoperative planning and perioperative guidance during RAPN. Control group: the use of only conventional CT imaging for preoperative planning and perioperative guidance during RAPN (= current standard of care). The primary endpoint is planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.
Sites
- AZORGAalst, Belgium
- AZ Sint-JanBruges, Belgium
- ZOLGenk, Belgium
- AZ Maria MiddelaresGhent, Belgium
- Ghent University HospitalGhent, Belgium