Status:
RECRUITING
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Stichting tegen Kanker
University Ghent
Conditions:
Kidney Cancer
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 rena...
Detailed Description
BACKGROUND: For patients diagnosed with localized kidney cancer, two main options exist to surgically remove the kidney tumor. During radical nephrectomy (RN), the entire kidney is removed. During pa...
Eligibility Criteria
Inclusion
- 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
- \> 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
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT06536439
Start Date
June 27 2024
End Date
January 1 2027
Last Update
April 1 2025
Active Locations (5)
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1
AZORG
Aalst, Belgium, 9300
2
AZ Sint-Jan
Bruges, Belgium, 8000
3
ZOL
Genk, Belgium, 3600
4
AZ Maria Middelares
Ghent, Belgium, 9000