Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536439
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Planning Operative Strategy Using a Digital Renal Artery Clamping Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PODRACING
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 tools 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
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 tools 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 11 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
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 tools 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None