Actively Recruiting
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Led by University Hospital, Ghent · Updated on 2025-04-01
235
Participants Needed
5
Research Sites
131 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
S
Stichting tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or above
- Diagnosed with cT1-2 N0 M0 renal mass
- Planned to undergo robot-assisted partial nephrectomy (RAPN)
- Multiphase CT scan with arterial phase available
- Voluntary and written informed consent given
- Sufficient in at least one of the study languages: Dutch, English, French
You will not qualify if you...
- More than 3 ipsilateral renal masses
- Women who are pregnant or breastfeeding
- Previous renal surgery expected to complicate renal cancer surgery
- Tumor stage cT 3 or higher
- Planned off-clamp resection
- Cognitive disorder impeding completion of study questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
J
Joris Vangeneugden, MD
CONTACT
C
Charles Van Praet, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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