Title: A multi-modality, surgical planning and guidance system to improve the up-take of laparoscopic liver resection
Funder: Department of Health and Social Care

Abstract: 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 &ndash; e.g. &ldquo;if I cut here, how much volume is left?&rdquo; 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.

Lay abstract: Liver cancer is a major global health problem affecting an estimated 1.4 million people every year in 2012. Liver cancers can be removed using open or keyhole (laparoscopic) surgery. Keyhole surgery is less daunting, results in less pain, fewer post-operative complications, faster recovery for the patient, shorter hospital stays and reduced cost. However, only 5-30% of liver surgery is carried out using the keyhole method as the surgeon is unable to feel the tumour in the liver, the surgical instruments are awkward, and the limited view means the surgeon may overlook problems, such as bleeding, outside the view of the keyhole camera. We have already developed an innovative prototype system, which aligns the liver surface seen in CT scans to the liver surface seen by the keyhole camera. Once aligned, the computer can display the CT data, on a monitor, aligned with the camera view of the liver. This may increase the safety and speed of the procedure and lead to an increased adoption of the keyhole approach. Initial patient trials at the Royal Free Hospital have demonstrated the feasibility and safety. In this project, we will develop 3 main things. Firstly, a range of planning tools to determine the best place to cut the liver and how much liver will remain. Secondly, we will develop the methods to enable theatre staff to quickly and easily setup the system in the operating room. Lastly, surgeons can use ultrasound during keyhole surgery to check the location of critical vessels within the liver and we will integrate ultrasound imaging within our system to make ultrasound easier to use. By the end of the project, a comprehensive system that is easy for surgical staff to use will be ready for clinical trial, and to be placed on the market.

Research activity codes: 5.4 SURGERY;6.4 SURGERY
Health categories: CANCER AND NEOPLASMS