Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
PODRACING
1 other identifier
interventional
235
1 country
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2024
CompletedFirst Submitted
Initial submission to the registry
July 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 1, 2025
March 1, 2025
2.5 years
July 15, 2024
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Selective clamping
Planning and performing as planned a selective clamping (SC) strategy (considered by the surgeon at the end of surgery, objectified pre- and postoperatively through online assessment on study website and controlled through video-analysis): planning SC and performing the planned SC strategy = positive outcome; planning SC and performing another SC strategy or full clamping (FC) = negative outcome; planning FC = negative outcome.
During surgery
Secondary Outcomes (4)
eGFR 6 months
6 months postoperatively
Clamping strategy
During surgery
Hilar dissection time
During surgery
Conversion to full clamp
During surgery
Other Outcomes (17)
Complications
90 days postoperatively
Estimated blood loss
During surgery
Perfusion model validation
During surgery
- +14 more other outcomes
Study Arms (2)
DIPLANN-tool + conventional CT imaging
EXPERIMENTALPre-operative planning and peri-operative guidance with DIPLANN-tool and conventional CT imaging.
Conventional CT imaging alone
ACTIVE COMPARATORPre-operative planning and peri-operative guidance with conventional CT imaging alone (standard of care).
Interventions
Pre-operative study visit explaining the RAPN procedure using the 3D model / DIPLANN-tool (with or without classical CT imaging). Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan.
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan.
Pre-operative study visit explaining the RAPN procedure using CT imaging alone. Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.
Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only.
Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Stichting tegen Kankercollaborator
- University Ghentcollaborator
Study Sites (5)
AZORG
Aalst, 9300, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
ZOL
Genk, 3600, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Related Publications (1)
Vangeneugden J, Vermijs S, De Backer P, Hemeryck B, Berquin C, De Visschere P, Decaestecker K, Debbaut C, Van Praet C. Three-dimensional Perfusion-zone Models Allow More Selective Clamping During Robot-assisted Partial Nephrectomy: Brief Report on a Retrospective Analysis. Eur Urol Open Sci. 2025 Nov 5;82:128-130. doi: 10.1016/j.euros.2025.10.013. eCollection 2025 Dec.
PMID: 41280160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Van Praet, MD, PhD
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2024
First Posted
August 5, 2024
Study Start
June 27, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 1, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share