NCT06536439Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 235 (estimated)
- First submitted
- 15 Jul 2024
- Start date
- 27 Jun 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Kidney cancer
- NCT number
- NCT06536439
What you commit to
- Study type: Interventional
- Planned participants: 235
- From 27 Jun 2024 to the primary completion date, 1 Jan 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous renal surgery that is expected to complicate renal cancer surgery
- planned off-clamp resection
Other illness
- cognitive disorder which impedes with completing study questionnaires
Other
- \> 3 ipsilateral renal masses
- women who are pregnant or breastfeeding
- cT ≥ 3
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| ZOL Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
Related publications
- Clinical trial protocol of PODRACING: A randomized controlled trial evaluating 3D perfusion zone models for selective arterial clamping during robot-assisted partial nephrectomy.BJUI Compass · 2026 · PMID 42022229
- Three-dimensional Perfusion-zone Models Allow More Selective Clamping During Robot-assisted Partial Nephrectomy: Brief Report on a Retrospective Analysis.Eur Urol Open Sci · 2025 · PMID 41280160
This page is information, not medical advice. Discuss any trial with your doctor.