Using a digital tool to improve kidney surgery planning
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
This study is testing a new digital tool to see if it helps doctors plan kidney surgery better for patients with localized kidney cancer compared to just using regular CT scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 5 sites (Aalst and 4 other locations) |
| Trial ID | NCT06536439 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with localized renal masses scheduled for robot-assisted partial nephrectomy.
Not a fit: Patients with advanced kidney cancer or those for whom partial nephrectomy is not feasible may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective kidney cancer surgeries with improved preservation of healthy kidney tissue.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for surgical planning, but the specific application of the DIPLANN-tool is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalst and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.