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Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Ghent
NCT06536439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, patient

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📋 Eligibility rules (as published)
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
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What it tests

  • Pre-operative explanation of the procedure (DIPLANN + CT)
  • Pre-operative surgical planning (DIPLANN + CT)
  • RAPN (DIPLANN + CT)
  • Pre-operative explanation of the procedure (CT only)
  • Pre-operative surgical planning (CT only)
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Where

5 sites
AZORG
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
ZOL
Genk, Belgium
AZ Maria Middelares
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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