NCT06536439

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Kidney Cancer
• Kidney Neoplasms
• Kidney Diseases
• Renal Cancer
• Renal Cell Carcinoma
• Renal Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-06-27
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-08-05
• Last updated: 2025-04-01

Locations

5 sites across 1 country: Belgium