Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Diseases | — | UNRESOLVED | — |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Renal Cancer | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Disease | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-operative explanation of the procedure (CT only) | Device | — | UNRESOLVED |
| Pre-operative explanation of the procedure (DIPLANN + CT) | Device | — | UNRESOLVED |
| Pre-operative surgical planning (CT only) | Device | — | UNRESOLVED |
| Pre-operative surgical planning (DIPLANN + CT) | Device | — | UNRESOLVED |
| RAPN (CT only) | Procedure | — | UNRESOLVED |
| RAPN (DIPLANN + CT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DIPLANN-tool + conventional CT imaging
- description
- Pre-operative planning and peri-operative guidance with DIPLANN-tool and conventional CT imaging.
- interventionNames
- Device: Pre-operative explanation of the procedure (DIPLANN + CT)
- Device: Pre-operative surgical planning (DIPLANN + CT)
- Procedure: RAPN (DIPLANN + CT)
- type
- ACTIVE_COMPARATOR
- label
- Conventional CT imaging alone
- description
- Pre-operative planning and peri-operative guidance with conventional CT imaging alone (standard of care).
- interventionNames
- Device: Pre-operative explanation of the procedure (CT only)
- Device: Pre-operative surgical planning (CT only)
- Procedure: RAPN (CT only)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDVangeneugden J, Vermijs S, De Backer P, Berquin C, Lumen N, De Kuyper P, Raskin Y, Bynens B, Baekelandt F, Ghysel C, Peeren F, De Groote R, De Naeyer G, Mottrie A, De Buyser S, De Visschere P, Debbaut C, Decaestecker K, Van Praet C. 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 Mar 30;7(4):e70191. doi: 10.1002/bco2.70191. eCollection 2026 Apr. PMID 42022229
- DERIVEDVangeneugden J, Vermijs S, De Backer P, Hemeryck B, Berquin C, De Visschere P, Decaestecker K, Debbaut C, Van Praet C. 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 Nov 5;82:128-130. doi: 10.1016/j.euros.2025.10.013. eCollection 2025 Dec. PMID 41280160