Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
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
University Hospital, Ghent
235 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
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 planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- \> 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
Interventions
Pre-operative study visit explaining the RAPN procedure using the 3D model / DIPLANN-tool (with or without classical CT imaging). Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan.
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan.
Pre-operative study visit explaining the RAPN procedure using CT imaging alone. Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only.
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only.
Locations(5)
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NCT06536439