Planning Operative Strategy Using a Digital Renal Artery Clamping Tool (PODRACING)

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool: a Randomized Controlled Trial Evaluating the DIPLANN 3D Model for Selective Arterial Clamping During Robot-Assisted Partial Nephrectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer; Kidney Neoplasms; Kidney Diseases; Renal Cell Carcinoma; Renal Cancer; Renal Disease
• Intervention / Treatment: 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)

Detailed Description

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:

• Whether SC is deemed possible according to the DIPLANN-tool in combination with conventional CT imaging or on conventional CT imaging alone, as assessed by an independent surgeon (between inclusion and randomization) who will not be not involved in the RAPN surgical procedure (yes vs no).
• Hospital where surgery is performed.
• PADUA classification (low (<8) and intermediate (8-9) vs high-risk (>9)). In case of multiple masses, the mass with the highest individual PADUA classification will be used.

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:

• 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.
• To compare the DIPLANN-tool in combination with conventional CT imaging to conventional CT imaging alone with respect to: patients' health, patients' insight, and surgeons' benefits.

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.

• Study Type: Interventional
• Enrollment (Estimated): 235
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joris Vangeneugden, MD; Phone Number: +32 9 332 22 76; Email: joris.vangeneugden@ugent.be
• Study Contact Backup: Name: Charles Van Praet, MD, PhD; Phone Number: +32 9 332 22 76; Email: charles.vanpraet@uzgent.be

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • AZORG
    • Contact: Alexandre Mottrie; Phone Number: +3253724448; Email: urologie.aalst@azorg.be
    • Contact: Alexandre Mottrie
    • Contact: Ruben De Groote
    • Contact: Frederick Peeren
    • Contact: Geert De Naeyer
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
    • Contact: Christophe Ghysel; Phone Number: +3250452530; Email: urologie@azsintjan.be
    • Contact: Christophe Ghysel
    • Contact: Frederic Baekelandt
  • Genk, Belgium, 3600
    • Recruiting
    • ZOL
    • Contact: Bernard Bynens; Phone Number: +3289808380; Email: secretariaat.urologie@zol.be
    • Contact: Bernard Bynens
    • Contact: Yannic Raskin
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Charles Van Praet, MD, PhD; Phone Number: +32 9 332 22 76; Email: charles.vanpraet@uzgent.be
    • Contact: Charles Van Praet, MD, PhD
    • Contact: Camille Berquin
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
    • Contact: Karel Decaestecker, MD, PhD
    • Contact: Karel Decaestecker, MD, PhD; Phone Number: +32 9 246 46 46; Email: secretariaat.urologie@mijnziekenhuis.be
    • Contact: Peter De kuyper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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:

• > 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIPLANN-tool + conventional CT imaging; Pre-operative planning and peri-operative guidance with DIPLANN-tool and conventional CT imaging.	Device: Pre-operative explanation of the procedure (DIPLANN + CT); 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.; Device: Pre-operative surgical planning (DIPLANN + CT); Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan.; Procedure: RAPN (DIPLANN + CT); Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan.
Active Comparator: Conventional CT imaging alone; Pre-operative planning and peri-operative guidance with conventional CT imaging alone (standard of care).	Device: Pre-operative explanation of the procedure (CT only); 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.; Device: Pre-operative surgical planning (CT only); Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only.; Procedure: RAPN (CT only); Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent; Stichting tegen Kanker
• Investigators: Principal Investigator: Charles Van Praet, MD, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Kidney Cancer; Minimally Invasive Surgery; Renal Cell Carcinoma; 3D; Robot-Assisted Surgery; Robot-Assisted Partial Nephrectomy; RAPN; Perfusion Zone
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Diseases; Kidney Neoplasms
• Other Study ID Numbers: ONZ-2023-0558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No