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Virtual 3D Modelling for Improved Surgical Planning of Robotic-assisted Partial Nephrectomy (VISP)

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Innersight3D
Sponsored by
Innersight Labs Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 18-80 years; Agreement at Multidisciplinary team meeting that this patient could undergo robotic-assisted partial nephrectomy.

Willing and able to provide written informed consent. RENAL score (tumour complexity) >= 8. Received contrast enhanced abdominal preoperative CT scan. Ability to understand and speak English.

Exclusion Criteria:

Do not consent for robotic assisted partial nephrectomy; Chose to have treatment outside one of the NHS trial sites. Participation in other clinical studies that would potentially confound this study; Have a horseshoe, a solitary kidney or bilateral kidney tumours; Lack of willingness to allow personal medical imaging data to be used for generating a 3D model;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention (3D model + CT for surgical planning)

    Control (CT for surgical planning)

    Arm Description

    Patients in this arm will receive a 3D model which will be used in addition to the CT scan for surgical planning.

    Patients in this arm will only have the a CT scan used for surgical planning.

    Outcomes

    Primary Outcome Measures

    Total Console time
    This is the time from the start of the robotic operation (arms start moving inside the abdomen) until the end of the robotic operation (arms have been taken out of the abdomen) and will be recorded using the robotic system

    Secondary Outcome Measures

    Artery preparation time (mins)
    Start time: From the point of dissection of gonadal vein. Stop time: As soon as arteries are isolated and ready for clamping.
    Tumour preparation time (mins)
    Start time: From the point of defatting the kidney (to isolate tumour) Stop time: As soon as the tumour is ready for ultrasound.
    Tumour resection time (mins)
    Start time: From the point of cutting of tumour Stop: Tumour is removed (excised)
    Hilar clamping technique
    What clamping technique was used to control blood flow. Choose from [Global ischemia, Selective ischemia, Clampless]
    Extirpative technique
    What technique was used to remove excise the tumour. Choose from [Enucleation, partial nephrectomyEnucleoresection (resection)] Choose from [Enucleation, partial nephrectomy]
    Opened collecting system [yes, no]
    Was the collecting system cut open during tumour resection?
    Conversion to radical nephrectomy [yes/no]
    Clamp time (mins)
    Time from when arteries are clamped to time until arteries are unclampsed are taken off. Also known as the warm ischemic time (WIT).
    Experience level of surgeon
    What is the experience level of the surgeon who is operating? Also were any registrars involved?
    Blood loss (ml)
    Total Operative time (mins)
    From the time that the patient enters the operating theatre to the point of exit, as recorded on the patient notes.
    Length of stay (days)
    This will be available following hospital discharge. If the patient is not discharged after 4 weeks following the surgery. A maximum length of 28 days should be entered and this along with the reasons should be captured on the adverse events log.
    Margin status on histology [positive/negative]
    The results from the histology report following the surgery should be recorded.
    Post-operative eGFR (ml/min)
    Measured 4 weeks after surgery
    Post-operative Hemoglobin (g/dL)
    Taken 1 day after surgery
    Clavien-Dindo Score
    Choose option from [Grade I, Grade II, Grade IIIa, Grade IIIb, Grade IVa, Grade IVb]

    Full Information

    First Posted
    October 26, 2021
    Last Updated
    October 26, 2021
    Sponsor
    Innersight Labs Ltd
    Collaborators
    Royal Free Hospital NHS Foundation Trust, Frimley Park Hospital NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, North Bristol NHS Trust, Guy's and St Thomas' NHS Foundation Trust, King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05109182
    Brief Title
    Virtual 3D Modelling for Improved Surgical Planning of Robotic-assisted Partial Nephrectomy
    Acronym
    VISP
    Official Title
    Virtual 3D Modelling for Improved Surgical Planning of Robotic-assisted Partial Nephrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Innersight Labs Ltd
    Collaborators
    Royal Free Hospital NHS Foundation Trust, Frimley Park Hospital NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, North Bristol NHS Trust, Guy's and St Thomas' NHS Foundation Trust, King's College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To establish whether surgical planning using virtual 3D modelling (Innersight 3D) improves the outcome and cost-effectiveness of RAPN, allowing more patients to benefit from minimally-invasive procedures.
    Detailed Description
    Surgery is the mainstay treatment for abdominal cancer, resulting in over 50,000 surgeries annually in the UK, with 10% of those being for kidney cancer. Preoperative surgery planning decisions are made by radiologists and surgeons upon viewing CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans. The challenge is to mentally reconstruct the patient's 3D anatomy from these 2D image slices, including tumour location and its relationship to nearby structures such as critical vessels. This process is time consuming and difficult, often resulting in human error and suboptimal decision-making. It is even more important to have a good surgical plan when the operation is to be performed in a minimally-invasive fashion, as it is a more challenging setting to rectify an unplanned complication than during open surgery (Byrn, et al. 2007). Therefore, better surgical planning tools are essential if we wish to improve patient outcome and reduce the cost of a surgical misadventure. To overcome the limitations of current surgery planning in a soft-tissue oncology setting, dedicated software packages and service providers have provided the capability of classifying the scan voxels into their anatomical components in a process known as image segmentation. Once segmented, stereolithography files are generated, which can be used to visualise the anatomy and have the components 3D printed. It has previously been reported that such 3D printed models influence surgical decision-making (Wake, et al. 2017). However, the financial and administrative costs of obtaining accurate 3D printed models for routine surgery planning has been speculated to be holding back 3D printed models from breaking into regular clinical usage (Western, 2017). Computational 3D surface-rendered virtual models have become a natural advancement from 3D printed models. In the literature, such models are referred to by a variety of names such as '3D-rendered images', (Zheng, et al. 2016), '3D reconstructions', (Isotani, et al. 2015), or 'virtual 3D models', (Wake, et al. 2017). In this protocol we will use the latter nomenclature. Previous studies have already shown that surgeons benefit from virtual 3D models in the theatre (Hughes-Hallett, 2014; Fan, et al. 2018; Fotouhi, et al. 2018). In a previous feasibility study (NIHR21460; IRAS 18/SW/0238), we used state-of-the-art CE marked software, called Innersight3D, to generate interactive virtual 3D models of the patient's unique anatomy from their received CT scans, to provide a detailed roadmap for the surgeon prior to the operation. We found that this approach had a positive influence on surgical decision-making. RAPN is a rapidly developing surgical field, with robots in 70+ UK surgical centres. The main research question to be addressed in the present study is, whether surgical planning using virtual 3D modelling (Innersight 3D) in a randomised controlled trial, improves the outcome and cost-effectiveness of RAPN. Patients will potentially benefit from this research for several reasons; Due to higher quality surgery and a reduced chance of complications, patients might go home sooner (Shirk, et al. 2018). Less likelihood of an unplanned conversion, which is when the surgeon has to abandon the minimally-invasive approach in favour of open surgery during the operation, due to unforeseen anatomical challenges. Improved patient empowerment and improved consenting, resulting in better patient decision-making. Our previous feasibility study showed that patients strongly agreed that 3D models improved their understanding of the disease treatment decisions and surgical planning. It could also reduce procedure time with less exposure to anesthetic. There are also operational benefits, as these models might improve prediction accuracy of operation complexity and operative time. Thus, surgery list scheduling and hospital-patient flow could be greatly improved. Waiting list could be reduced because of less operations overrun. In addition, surgical team cohesion could also be enhanced. A reduction in theatre time, length-of-stay, would have financial benefits for the health service.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This RCT, is a multi-centre main trial and will recruit patients selected for minimally-invasive robotic-assisted renal cancer surgery during the enrolment period. The study will compare current surgical planning method to planning with the addition of virtual 3D models in randomised patient groups. There are no clinical treatment changes/interventions in addition to the standard-of-care procedures. Participants will have 3D models of their anatomy built, clinical team and participant feedback will be obtained in the form of a survey, and the measurability of the key trial outcomes will be assessed as outlined below. Patient participation in the trial is expected to take no longer than 9 weeks, including a 4-week follow-up, from the initial participant information meeting. Methods used to assess outcomes will employ medical data analysis, participant opinion and observational measurements.
    Masking
    Investigator
    Masking Description
    The following will be blinded: Chief Investigator, Senior Statistician, Research Nurses, Trial Steering Committee The following will be unblinded: Principal Investigators at site, Trial Manager/monitor, Junior Statistician, Trial Participants, Treating clinicians, Data Monitoring Committee
    Allocation
    Randomized
    Enrollment
    328 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention (3D model + CT for surgical planning)
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive a 3D model which will be used in addition to the CT scan for surgical planning.
    Arm Title
    Control (CT for surgical planning)
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will only have the a CT scan used for surgical planning.
    Intervention Type
    Device
    Intervention Name(s)
    Innersight3D
    Intervention Description
    Innersight3D generates a virtual interactive 3D model of the CT scan.
    Primary Outcome Measure Information:
    Title
    Total Console time
    Description
    This is the time from the start of the robotic operation (arms start moving inside the abdomen) until the end of the robotic operation (arms have been taken out of the abdomen) and will be recorded using the robotic system
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Artery preparation time (mins)
    Description
    Start time: From the point of dissection of gonadal vein. Stop time: As soon as arteries are isolated and ready for clamping.
    Time Frame
    18 months
    Title
    Tumour preparation time (mins)
    Description
    Start time: From the point of defatting the kidney (to isolate tumour) Stop time: As soon as the tumour is ready for ultrasound.
    Time Frame
    18 months
    Title
    Tumour resection time (mins)
    Description
    Start time: From the point of cutting of tumour Stop: Tumour is removed (excised)
    Time Frame
    18 months
    Title
    Hilar clamping technique
    Description
    What clamping technique was used to control blood flow. Choose from [Global ischemia, Selective ischemia, Clampless]
    Time Frame
    18 months
    Title
    Extirpative technique
    Description
    What technique was used to remove excise the tumour. Choose from [Enucleation, partial nephrectomyEnucleoresection (resection)] Choose from [Enucleation, partial nephrectomy]
    Time Frame
    18 months
    Title
    Opened collecting system [yes, no]
    Description
    Was the collecting system cut open during tumour resection?
    Time Frame
    18 months
    Title
    Conversion to radical nephrectomy [yes/no]
    Time Frame
    18 months
    Title
    Clamp time (mins)
    Description
    Time from when arteries are clamped to time until arteries are unclampsed are taken off. Also known as the warm ischemic time (WIT).
    Time Frame
    18 months
    Title
    Experience level of surgeon
    Description
    What is the experience level of the surgeon who is operating? Also were any registrars involved?
    Time Frame
    18 months
    Title
    Blood loss (ml)
    Time Frame
    18 months
    Title
    Total Operative time (mins)
    Description
    From the time that the patient enters the operating theatre to the point of exit, as recorded on the patient notes.
    Time Frame
    18 months
    Title
    Length of stay (days)
    Description
    This will be available following hospital discharge. If the patient is not discharged after 4 weeks following the surgery. A maximum length of 28 days should be entered and this along with the reasons should be captured on the adverse events log.
    Time Frame
    18 months
    Title
    Margin status on histology [positive/negative]
    Description
    The results from the histology report following the surgery should be recorded.
    Time Frame
    18 months
    Title
    Post-operative eGFR (ml/min)
    Description
    Measured 4 weeks after surgery
    Time Frame
    18 months
    Title
    Post-operative Hemoglobin (g/dL)
    Description
    Taken 1 day after surgery
    Time Frame
    18 months
    Title
    Clavien-Dindo Score
    Description
    Choose option from [Grade I, Grade II, Grade IIIa, Grade IIIb, Grade IVa, Grade IVb]
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged 18-80 years; Agreement at Multidisciplinary team meeting that this patient could undergo robotic-assisted partial nephrectomy. Willing and able to provide written informed consent. RENAL score (tumour complexity) >= 8. Received contrast enhanced abdominal preoperative CT scan. Ability to understand and speak English. Exclusion Criteria: Do not consent for robotic assisted partial nephrectomy; Chose to have treatment outside one of the NHS trial sites. Participation in other clinical studies that would potentially confound this study; Have a horseshoe, a solitary kidney or bilateral kidney tumours; Lack of willingness to allow personal medical imaging data to be used for generating a 3D model;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lorenz Berger, PhD
    Phone
    07979067365
    Email
    lorenz@innersightlabs.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Virtual 3D Modelling for Improved Surgical Planning of Robotic-assisted Partial Nephrectomy

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