Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

Launched by UNIVERSITY HOSPITAL, GHENT · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the DIPLANN-tool, which helps doctors plan kidney surgery for patients with localized kidney cancer. The tool uses advanced 3D imaging to predict blood flow in the kidney, allowing surgeons to selectively clamp blood vessels during the operation. This study aims to see if using the DIPLANN-tool, along with standard CT scans, improves the planning and success of the surgery compared to using just the CT scans, which is the current method.

To participate in the trial, you need to be at least 18 years old and have a specific type of kidney tumor that is not too advanced. You should also be scheduled for robot-assisted partial nephrectomy (RAPN), a type of kidney surgery. Participants will be randomly assigned to either use the DIPLANN-tool with CT imaging or just the CT imaging alone. Throughout the trial, you can expect regular check-ins and to provide feedback on your health and experience. This research is important because it could lead to better surgical outcomes for patients with kidney cancer.

Gender

ALL

Eligibility criteria

• 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 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 Criteria:
• • \> 3 ipsilateral renal masses
• • women who are pregnant or breastfeeding
• • previous renal surgery that is expected to complicate renal cancer surgery
• • cT ≥ 3
• • planned off-clamp resection
• • cognitive disorder which impedes with completing study questionnaires