Kidney Neoplasms Clinical Trial
Official title:
Single-site Single-arm Feasibility Study of Patient-specific Interactive 3D Anatomical Models Aimed at Improving Surgery Planning Processes for Complex Renal Cancer Patients
This study aims to determine the feasibility of undertaking a future definitive RCT to
evaluate the clinical effectiveness of complementing existing medical scans with a
patient-specific interactive 3D virtual model of the patient's body to assist the surgeon
with planning for the operation in the best way possible. Renal cancer patients receive a
tri-phasic CT scan as routine practice, thus if the standard imaging protocols are followed,
there should be ample imaging data available for 3D model creation.
This study is a single-site, single-arm, unblinded, prospective, feasibility study aiming to
recruit 24 participants from the Royal Free Hospital that are scheduled for robotic-assisted
partial nephrectomy. Consenting participants will be recruited over a 6-month period, and
interactive 3D virtual models of their anatomy will be generated. These models will be used
to aid surgeon-patient communications and to plan for the operation. This study will
determine whether a definitive RCT of virtual 3D models as an adjunct to surgery planning is
feasible with respect to: recruitment of local authorities and patients; ensuring staff can
be adequately trained to deliver programmes within specified timeframes; and assessment of
the measurability of key surgical outcomes.
Surgery is the mainstay treatment for abdominal cancer, resulting in over 50,000 surgeries
annually in the UK, with 10% of those being for renal cancer. Preoperative surgery planning
decisions are made by radiologists and surgeons upon viewing CT and MRI 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 more challenging setting to rectify
an unplanned complication than during open surgery. Therefore, better surgical planning tools
are essential if one is to improve patient outcome and reduce the cost of 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
(see Section 6.1 for more information). Once segmented, stereolithography files are generated
which can be used to visualise the anatomy and have the components 3D printed. It has
previously been shown that such 3D printed models influence surgical decision-making.
However, the relevance of a physical model to plan for a minimally invasive surgical approach
is debatable, and 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.
As a necessary precursor to 3D printed models, computational 3D surface-rendered virtual
models could be used by the urologist to assist with clinical decision-making. In the
literature, such models are referred to by a variety of names such as '3D-rendered images',
'3D reconstructions', or 'virtual 3D models'. In this protocol, the investigators will use
the latter nomenclature. Virtual 3D models provide many of the advantages of their physical
3D printed counterpart without the challenge of the printing process, they can be easily
viewed on standard digital devices such as laptops or smartphones and can be simultaneously
viewed and interacted with from anywhere in the world, which could help with collaborative
surgery planning between centres. Note that this study's use of virtual 3D models is not to
be confused with Virtual-Reality visualisation, which is an immersive environment and
currently requires specialist equipment. In support of this study, previous pioneering
studies have already shown that surgeons benefit from computational 3D models in the theatre.
However, in addition to the available 2D medical images (CT, MRI, volume-rendered images), it
has not been shown that virtual 3D models, constructed from the same existing medical scan
data, would influence the surgical decision-making process or alter surgeon confidence in
their decisions. Crucially, it also remains to be shown that such 3D models can be built
reliably and at scale to facilitate their widespread adoption.
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