Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
NCT Number: NCT06536439
Acronym: PODRACING
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Cancer|Kidney Neoplasms|Kidney Diseases|Renal Cancer|Renal Cell Carcinoma|Renal Disease
Interventions: DEVICE: Pre-operative explanation of the procedure (DIPLANN + CT)|DEVICE: Pre-operative surgical planning (DIPLANN + CT)|PROCEDURE: RAPN (DIPLANN + CT)|DEVICE: Pre-operative explanation of the procedure (CT only)|DEVICE: Pre-operative surgical planning (CT only)|PROCEDURE: RAPN (CT only)
Sponsor: University Hospital, Ghent
Collaborators: University Ghent|Stichting tegen Kanker
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 235
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-12-27
Locations: AZ Maria Middelares, Ghent, 9000, Belgium|Ghent University Hospital, Ghent, 9000, Belgium

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.

Primary Outcome Measures: 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 Outcome Measures: eGFR 6 months, Change in eGFR at 6 months after surgery compared to eGFR preoperatively., 6 months postoperatively|Clamping strategy, Clamping strategy performed (selective clamping or full clamping)., During surgery|Hilar dissection time, Time to dissect hilum (minutes) as analyzed on postoperative surgical video analysis., During surgery|Conversion to full clamp, Conversion from SC to FC., During surgery
Other Outcome Measures: Complications, Intra-operative and 90-day postoperative complications., 90 days postoperatively|Estimated blood loss, Estimated blood loss during surgery (mL)., During surgery|Perfusion model validation, Concordance between 3D perfusion model and peroperative kidney surface perfusion as visualized by ICG as estimated by postoperative surgical video analysis., During surgery|Low eGFR 6 months, eGFR (CKD-EPI) \<45 ml/min at 6 months after surgery., 6 months postoperatively|Postoperative eGFR, Change in eGFR (CKD-EPI) after surgery at other time points up to 1 year (postoperative day 1, last measurement before discharge, postoperatively 1 month, 3 months, 12 months) compared to eGFR preoperatively., up to 12 months postoperatively|Ischemia time, Ischemia time during surgery (seconds)., During surgery|Positive surgical margin rate, Positive surgical margin (PSM), as analyzed on histopathological examination., Postoperatively on average 10 days after surgery|Console time, Robotic console time of surgery (minutes)., During surgery|Hospital stay, Length of hospital stay after surgery (days)., From day of surgery to day of discharge from the hospital: number of days includes day of the surgery as the first day and day of discharge from the hospital as the final day (estimated at 3 days, longer if more complicated hospitalisation)|Patient quality of life, Quality of life (according to the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire: higher score = worse quality of life) up until 1 year after surgery (preoperatively, postoperatively at 3 months, 6 months, 12 months)., up to 12 months postoperatively|Anxiety 1, Preoperative anxiety for surgery questionnaire: Hospital Anxiety and Depression Scale (HADS): higher score = more anxiety., Preoperatively|Anxiety 2, Preoperative anxiety for surgery questionnaire: Symptom Distress Thermometer (SDT): higher score = more anxiety., Preoperatively|Patient knowledge, Preoperative patient knowledge questionnaire. Higher score = more knowledge., Preoperatively|Kidney dissection time, Time to dissect kidney (minutes) as analyzed on postoperative surgical video analysis., During surgery|Superselective clamping rate, Superselective clamping (yes/no) as analyzed on postoperative surgical video analysis., During surgery|Ischemic renal parenchyma, Percent renal parenchyma rendered ischemic., During surgery|Conversion rate, Conversion from partial to radical nephrectomy., During surgery