NCT06536439 Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
| NCT ID | NCT06536439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Kidney Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 235 participants in total. It began in 2024-06-27 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Charles Van Praet, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06536439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06536439 currently recruiting?
Yes, NCT06536439 is actively recruiting participants. Contact the research team at joris.vangeneugden@ugent.be for enrollment information.
Where is the NCT06536439 trial being conducted?
This trial is being conducted at Aalst, Belgium, Bruges, Belgium, Genk, Belgium, Ghent, Belgium and 1 additional location.
Who is sponsoring the NCT06536439 clinical trial?
NCT06536439 is sponsored by University Hospital, Ghent. The principal investigator is Charles Van Praet, MD, PhD at University Hospital, Ghent. The trial plans to enroll 235 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.