Clinical trial protocol of PODRACING: A randomized controlled trial evaluating 3D perfusion zone models for selective arterial clamping during robot-assisted partial nephrectomy.

BACKGROUND

Performing partial nephrectomy (PN) for suspected renal cell carcinoma (RCC) requires a careful clamping strategy to balance blood loss and postoperative kidney function. For better prediction of individual kidney perfusion, the proposed DIPLANN-tool visualizes arterial perfusion zones using 3D models from CT scans to support surgeons in planning selective clamping (SC). We hypothesize that using 3D perfusion zone (3DPZ) models allows for more frequent and more accurate SC during robot-assisted PN (RAPN). Furthermore, it might also benefit patients' health and insight.

STUDY

DESIGN

PODRACING (Planning Operative strategy using a Digital Renal Artery ClampING tool) is a multicentre randomized controlled trial, evaluating the potential benefits of 3DPZ models. Patients will be randomized 1:1 to either the experimental group (DIPLANN-tool + CT) or the control group (conventional CT alone).

ENDPOINTS: The primary endpoint entails planning and performing, as planned, an SC strategy. Key secondary endpoints include the performed clamping strategy (SC vs main artery clamping [MAC]) and the difference in kidney function at 6 months postoperative. Other secondary and exploratory outcomes include different aspects regarding patients' health, patients' insight and surgeons' benefits.

PATIENTS AND

METHODS

All adult patients with cT1-2 N0 M0 renal cancer planned to undergo RAPN with multiphase CT scan with arterial phase available are eligible for inclusion. Apart from the availability of a 3DPZ model (during a preoperative study visit, while planning the surgical strategy and intraoperatively), study procedures are identical for the study group and control group. For the primary endpoint, the surgeon needs to lock his/her final clamping strategy on the study website. The surgeon can use his/her preferred operating method for RAPN (no limitations in surgical approach or robotic system) and postoperative hospitalization course. Postoperative visits entail visits at 1 month, 3 months, 6 months and 12 months.

REGISTRATION: The trial is registered on ClinicalTrials.gov with identifier NCT06536439.1 The study was approved by the Belgian Federal Agency for Medicines and Health Products. Eudamed number: CIV-23-11-044854.