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临床试验/NCT03606044
NCT03606044已完成不适用

Single-site Single-arm Feasibility Study of Patient-specific Interactive 3D Anatomical Models Aimed at Improving Surgery Planning Processes for Complex Renal Cancer Patients

Dr Eoin R Hyde1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Study participant recruitment rate as assessed by number of participants divided by the total number of invited eligible patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 - 80 years, inclusive;
  • Male and female;
  • Diagnosed with T1a, or T1b renal tumours;
  • Suitable for elective robot-assisted partial nephrectomy;
  • Willing and able to provide written informed consent.

排除标准

  • aged <18 or >80 years;
  • have had prior abdominal surgery;
  • have had pre-operative imaging that is not adherent to the study protocol;
  • contraindicated for biopsy;
  • do not consent to have biopsy;
  • have a body mass index (BMI) ≥35 kg/m^2;
  • have a bleeding disorder;
  • have baseline chronic kidney disease (CKD);
  • not fit or do not consent for surgery;
  • chose to have treatment outside the Royal Free Hospital;
  • participation in other clinical studies that would potentially confound this study;
  • unable to understand English;
  • unable to provide consent themselves;

结局指标

主要结局

Study participant recruitment rate as assessed by number of participants divided by the total number of invited eligible patients.

时间窗: 6 months

Determination of participant recruitment rates of eligible patients to this study. Assessment: ratio of consenting patients to eligible patients

次要结局

  • Feasibility of measuring of post-operative number of haemorrhage events.(6 months)
  • Surveying patient opinion on the usefulness of 3D models.(6 months)
  • Feasibility of measuring of peri-operative operation time.(6 months)
  • Feasibility of measuring of peri-operative acute haemorrhage events.(6 months)
  • Feasibility of measuring of peri-operative blood loss.(6 months)
  • Feasibility of measuring of post-operative participant length-of-stay in hosital.(6 months)
  • Feasibility of measuring of post-operative number of surgical site infection events.(6 months)
  • Ratio of study participants willing to be randomized.(6 months)
  • Feasibility of measuring of peri-operative number of transfusion events.(6 months)
  • Time spent by surgeons in pre-operative planning.(6 months)
  • Practicality of delivering the patient-specific 3D model to the Operating Room.(6 months)

研究者

发起方
Dr Eoin R Hyde
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Dr Eoin R Hyde

Co-Investigator

Innersight Labs Ltd

研究点 (1)

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