A multi-modality, surgical planning and guidance system to improve the up-take of laparoscopic liver resection

For the proposed project, we request funding for 3 years, covering 3 post-doctoral research associates and 1 clinical fellow. The work will be split into the following work packages (WP): WP 1: Design of clamp and calibration objects: A clamp for tracking markers, a tracked calibration target consisting of a pattern of features and an electro-magnetic to optical tracker calibration object will be designed and manufactured on auto-clavable or single-use material. We will collaborate with Maddison Product Design Ltd to design the products and produce a technical file suitable for C.E. marking. In collaboration with MDM Ltd, our QMS will be extended to cover the design of such physical objects. We already have the capability to develop C.E. marked medical device software. WP 2: Planning software: Existing companies provide services to segment anatomical structures from CT scans, but the analysis tools are not available within a surgical software suite, during surgery. An integrated planning module will be implemented, that can be used both pre-operatively and intra-operatively before resection commences. It will measure features such as the extent (volume/percentage) of liver resection, tumour location and size and proximity to major blood vessels. The key novelty will be intra-operative prospective analysis – e.g. "if I cut here, how much volume is left?" WP 3: Human factors: From our experience on the Smart Liver project, a key challenge is usability. We will perform lab based experiments, to quantify surgeon performance in the lab, improve design and measure performance on clinical cases. WP 4: Technical file preparation: We will produce a technical file, suitable for application to the MHRA for a future clinical trial. WP 5: Ultrasound rigid registration: We have prototyped feature based ultrasound to CT registration based on internal vessels (Song et al. 2015). We will investigate using electro-magnetically (EM) tracked laparoscopic ultrasound probes to provide more dense volume based methods, and propose a novel, more clinically applicable registration method. We will develop optical to EM calibration methods, and ultrasound to EM calibration methods. A physical phantom will be designed and constructed for the purpose of validating the ultrasound based registration accuracy. WP 6: Clinical evaluation: For the first 18 months of the project, we will evaluate the system during surgical cases on Prof. Brian Davidson s list, with patients undergoing laparoscopic liver resection or laparoscopic staging procedures. Surgeon questionnaires, and quantitative measures such as the time required to calibrate and register will be recorded. WP 7: Feasibility study: For the last 18 months, a feasibility study will be performed, covering 1-2 patients per month, with those patients eligible for laparoscopic liver resection or laparoscopic staging procedures at the Royal Free Hospital. Patients will have operative evaluation, data collected on post-operative outcome and during 3 months follow up. The primary outcome is health related quality of life at baseline, 1 and 3 months. Secondary outcomes will include: number of patients meeting eligibility criteria, recruitment rate, system setup-time, time-to-register system, surgeon feedback, outcome of surgery (morbidity and mortality), blood loss, ITU and hospital stay, outpatient visits or readmissions and loss to follow up. Analysis: This is a feasibility study, not powered to detect difference in outcomes, so the output will be descriptive statistics. WP 8: Commercialisation Activity: Throughout the proposed project, we will protect intellectual property, perform another round of freedom to operate searches and finalise a commercialisation strategy based on either a development and licensing agreement with a medical device company or via a spin-out.