Actively Recruiting
Led by University Hospital, Ghent · Updated on 2025-04-01
235
Participants Needed
5
Research Sites
N/A
Total Duration
U
University Hospital, Ghent
Lead Sponsor
S
Stichting tegen Kanker
Collaborating Sponsor
Researchers are investigating a new digital tool called the DIPLANN-tool to help plan kidney surgeries for patients with localized kidney cancer. This tool predicts kidney blood flow zones on a 3D model to guide selective clamping during robot-assisted partial nephrectomy (RAPN). The study aims to confirm if adding the DIPLANN-tool to conventional CT imaging improves surgical planning and outcomes compared to using CT imaging alone. Participants will be randomly assigned to one of two groups: one group will use the DIPLANN-tool combined with conventional CT imaging for preoperative planning and guidance during RAPN, while the other group will use only conventional CT imaging, which is the current standard of care. The study involves preoperative visits with physical exams, blood tests, and questionnaires, followed by the surgical procedure guided by the assigned imaging method. During the study, patients will undergo assessments including physical exams, blood tests, and questionnaires to evaluate health, anxiety, and quality of life before surgery. Researchers will measure how well selective clamping is planned and performed during surgery as the main outcome. Secondary outcomes include kidney function six months after surgery, surgical details like clamping strategy and dissection time, and any need to switch to full clamping. The study will track these results to assess the benefits of the DIPLANN-tool over standard imaging.
CONDITIONS
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants attend a pre-operative study visit where the surgical procedure and clamping strategy are explained and planned using either the DIPLANN-tool with conventional CT imaging or conventional CT imaging alone. This includes a physical examination, blood tests, and questionnaires about patient knowledge, anxiety, and quality of life.
1 visit (in-person)
Duration - Day of surgery
Participants undergo robot-assisted partial nephrectomy with peri-operative guidance using either the DIPLANN-tool plus CT imaging or CT imaging alone to assist in selective arterial clamping during the procedure.
1 visit (in-person, surgical procedure)
Duration - 6 months postoperatively
Participants are monitored for health outcomes including kidney function and recovery after surgery.
Follow-up visits as scheduled by the clinical team
Total: 5 locations
1
AZORG
Aalst, Belgium, 9300
Actively Recruiting
2
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
3
ZOL
Genk, Belgium, 3600
Actively Recruiting
4
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
5
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
J
Joris Vangeneugden, MD
C
Charles Van Praet, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Joris Vangeneugden, Saar Vermijs, Pieter De Backer...
https://pubmed.ncbi.nlm.nih.gov/42022229Joris Vangeneugden, Saar Vermijs, Pieter De Backer...
https://pubmed.ncbi.nlm.nih.gov/41280160