Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
Qualifiers
aged 18 years or above
cT1-2 N0 M0 renal mass
planned to undergo RAPN
multiphase CT scan with arterial phase available
Disqualifiers
> 3 ipsilateral renal masses
women who are pregnant or breastfeeding
previous renal surgery that is expected to complicate renal cancer surgery
cT ≥ 3
Trial design
Treatments tested in this trial
- Pre-operative explanation of the procedure (DIPLANN + CT)
- Pre-operative surgical planning (DIPLANN + CT)
- RAPN (DIPLANN + CT)
- Pre-operative explanation of the procedure (CT only)
- Pre-operative surgical planning (CT only)
- RAPN (CT only)
Treatment groups
235 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Ghent
Lead sponsor
Stichting tegen Kanker
Collaborator
University Ghent
Collaborator
Source ClinicalTrials.gov