Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
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 v
| Condition(s) | Kidney Cancer, Kidney Neoplasms, Kidney Diseases, Renal Cancer, Renal Cell Carcinoma, Renal Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 planni |
| Who can participate | Inclusion Criteria: * 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 techni |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Ghent |
| Locations | Aalst, Belgium; Bruges, Belgium; Genk, Belgium; Ghent, Belgium; Ghent, Belgium |
| Start date | 2024-06-27 |
| NCT ID | NCT06536439 |
| Official listing | https://clinicaltrials.gov/study/NCT06536439 |