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| Name | Class |
|---|---|
| Stichting tegen Kanker | OTHER |
| University Ghent | OTHER |
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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.
BACKGROUND:
For patients diagnosed with localized kidney cancer, two main options exist to surgically remove the kidney tumor. During radical nephrectomy (RN), the entire kidney is removed. During partial nephrectomy (PN), only the tumor is resected, safeguarding the function of the remaining healthy kidney tissue. This last procedure is preferred, but not always technically feasible. To resect only the tumor, a balance has to be found in the clamping approach: clamping the blood supply to the kidney assures bloodless tumor resection, yet compromises the postoperative renal function due to the temporary ischemia. Tumor resection without clamping on the other hand, might lead to substantial blood loss. That is why "selective clamping" (SC) is proposed. In this approach, only those selective arteries are clamped that perfuse the zone including the tumor. The main drawback of this strategy is that it is often not clear which arteries should be clamped based on standard preoperative imaging, while misjudgment can lead to a high-risk surgery with excessive bleeding or prolonged ischemia time. Therefore, RN is currently recommended when PN is considered not feasible. Better prediction of individual kidney perfusion will allow to perform more frequently a PN and thus save healthier kidney tissue. Additionally, it is difficult for patients to assess their own individual oncological situation based on 2D CT images.
With this project, the investigators want to offer the surgeon an easy-to-use virtual planning tool that facilitates the decision-making process regarding the feasibility of PN and the corresponding optimal clamping strategy. This tool uses virtual 3D models based on CT scans, to visualize precise information on the different anatomical structures and perfusion zones. This may also improve patients' understanding of their own individual situation. The proposed new tool (DIPLANN-tool) 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.
DESIGN:
A confirmatory, multicentric, unblinded, randomized, controlled, pivotal trial using parallel group assignment and stratified randomization.
Experimental group: the use of the DIPLANN model + conventional CT imaging for preoperative planning and perioperative guidance.
Control group: the use of only conventional CT imaging for preoperative planning and perioperative guidance (= current standard of care).
METHODOLOGY:
Sample size calculation: 235 patients.
Patients will be randomized according to a 1:1 allocation ratio to either the experimental group (the DIPLANN-tool in combination with conventional CT imaging) or the control group (conventional CT imaging alone), using permuted block randomization with blocks of varying size.
Randomization will be stratified on the following variables:
PRIMARY OBJECTIVE:
To assess if the DIPLANN-tool in combination with conventional CT imaging is superior to conventional CT imaging alone, with respect to planning and performing as planned a SC strategy during RAPN, in patients diagnosed with localized kidney cancer who are planned to undergo renal cancer surgery and in whom SC is deemed possible either according to the DIPLANN-tool in combination with conventional CT imaging or according to conventional CT imaging only, as assessed between inclusion and randomization by an independent surgeon.
SECONDARY OBJECTIVES:
ENDPOINTS:
The primary endpoint is planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.
Extended listing of all outcome measures: see below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIPLANN-tool + conventional CT imaging | Experimental | Pre-operative planning and peri-operative guidance with DIPLANN-tool and conventional CT imaging. |
|
| Conventional CT imaging alone | Active Comparator | Pre-operative planning and peri-operative guidance with conventional CT imaging alone (standard of care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative explanation of the procedure (DIPLANN + CT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Intra-operative and 90-day postoperative complications. | 90 days postoperatively |
| Estimated blood loss | Estimated blood loss during surgery (mL). |
Inclusion Criteria:
For the primary objective, SC needs to be deemed possible either according to the DIPLANN-tool in combination with conventional CT imaging or according to conventional CT imaging only, as assessed by an independent surgeon (between inclusion and randomization) who will not be involved in the RAPN surgical procedure, in order to be included in the analysis set. On the DIPLANN tool, SC is deemed feasible if >= 90% tumor ischemia and <= 70% renal parenchyma ischemia can be achieved. If these criteria are met, but it is technically or anatomically not feasible according to the independent surgeon to perform SC, he can deviate from these criteria and thus claim SC is not deemed possible. The results for the total population (patients in which SC is deemed possible AND impossible pre-operatively by an independent surgeon) will also be analyzed as a secondary objective.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joris Vangeneugden, MD | Contact | +32 9 332 22 76 | joris.vangeneugden@ugent.be | |
| Charles Van Praet, MD, PhD | Contact | +32 9 332 22 76 | charles.vanpraet@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Charles Van Praet, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG | Recruiting | Aalst | 9300 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42022229 | Derived | Vangeneugden J, Vermijs S, De Backer P, Berquin C, Lumen N, De Kuyper P, Raskin Y, Bynens B, Baekelandt F, Ghysel C, Peeren F, De Groote R, De Naeyer G, Mottrie A, De Buyser S, De Visschere P, Debbaut C, Decaestecker K, Van Praet C. Clinical trial protocol of PODRACING: A randomized controlled trial evaluating 3D perfusion zone models for selective arterial clamping during robot-assisted partial nephrectomy. BJUI Compass. 2026 Mar 30;7(4):e70191. doi: 10.1002/bco2.70191. eCollection 2026 Apr. | |
| 41280160 |
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Confirmatory, multicentric, unblinded, randomized, controlled, pivotal trial using parallel group assignment and stratified randomization.
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|
| Pre-operative surgical planning (DIPLANN + CT) | Device | Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan. |
|
| RAPN (DIPLANN + CT) | Procedure | Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan. |
|
| Pre-operative explanation of the procedure (CT only) | Device | 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. |
|
| Pre-operative surgical planning (CT only) | Device | Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only. |
|
| RAPN (CT only) | Procedure | Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only. |
|
| 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 |
| 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 |
| AZ Sint-Jan | Recruiting | Bruges | 8000 | Belgium |
|
| ZOL | Recruiting | Genk | 3600 | Belgium |
|
| AZ Maria Middelares | Recruiting | Ghent | 9000 | Belgium |
|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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