Using a digital tool to improve kidney surgery planning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a new digital tool, the DIPLANN-tool, designed to enhance preoperative planning for robot-assisted partial nephrectomy (RAPN) in patients with localized kidney cancer. The trial compares outcomes between patients using the DIPLANN-tool alongside conventional CT imaging and those using only conventional CT imaging for surgical planning. The primary goal is to determine the feasibility of selective clamping of renal arteries during surgery, which could lead to better preservation of kidney function. Secondary endpoints include assessing patient health, insights, and benefits for surgeons involved in the procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Azorg
  Aalst, Belgium Recruiting
• AZ Sint-Jan
  Bruges, Belgium Recruiting
• Zol
  Genk, Belgium Recruiting
• AZ Maria Middelares
  Ghent, Belgium Recruiting
• Ghent University Hospital
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Charles Van Praet, MD, PhD — University Hospital, Ghent
• Study coordinator: Joris Vangeneugden, MD
• Email: joris.vangeneugden@ugent.be
• Phone: +32 9 332 22 76

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.