Planning Kidney Surgery With a Digital 3D Model for Kidney Cancer Patients
Tests a digital 3D kidney model to plan robot-assisted surgery in adults with kidney cancer.
Plain-language title generated from the registry record
Registry title: Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Key facts
- Where
- Aalst, Bruges, Genk, and Ghent, BelgiumSee the 5 sites
Where in Belgium
- AZORGAalst, BelgiumTaking people
- AZ Sint JanBruges, BelgiumTaking people
- ZOLGenk, BelgiumTaking people
- AZ Maria MiddelaresGhent, BelgiumTaking people
- Ghent university hospitalGhent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Ghent
- Trial code
- NCT06536439
- Record updated
- 1 April 2025
- Original description
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.Read full original descriptionShow less
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool: a Randomized Controlled Trial Evaluating the DIPLANN 3D Model for Selective Arterial Clamping During Robot-Assisted Partial Nephrectomy
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.
Inclusion: aged 18 years or above; cT1-2 N0 M0 renal mass; planned to undergo RAPN; multiphase CT scan with arterial phase available; voluntary given and written informed consent; sufficient in at least one of the study languages: Dutch, English, French; For the primary objective, SC needs to be deemed possible either according to the DIPLANN-tool in combination with conventional CT imaging or according to conventional CT imaging only, as assessed by an independent surgeon (between inclusion and randomization) who will not be involved in the RAPN surgical procedure, in order to be included in the analysis set. On the DIPLANN tool, SC is deemed feasible if >= 90% tumor ischemia and <= 70% renal parenchyma ischemia can be achieved. If these criteria are met, but it is technically or anatomically not feasible according to the independent surgeon to perform SC, he can deviate from these criteria and thus claim SC is not deemed possible. The results for the total population (patients in which SC is deemed possible AND impossible pre-operatively by an independent surgeon) will also be analyzed as a secondary objective.
Exclusion: previous renal surgery that is expected to complicate renal cancer surgery; planned off-clamp resection; cognitive disorder which impedes with completing study questionnaires; > 3 ipsilateral renal masses; women who are pregnant or breastfeeding; cT ≥ 3.