Title: Hepatopancreatobiliary (HPB)
Funder: Department of Health and Social Care

Abstract: The HPB theme will align to the overall MIC strategy, drawing on strengths in the 5 supporting work streams. It will bring together the HPB clinical community with academia, patients and public, industry, and other related NIHR and MedTech partners, to form a dynamic network focused on the development and translation of new surgical technologies to treat HPB disease. The MIC 5-step approach to innovation will be used as a model to progress unmet needs through to clinical translation. Short term objectives (Year 1): Objective 1: to embed HPB surgery as a theme within MIC Surgical Technologies with national reach and influence. The theme lead will work closely with the MIC central office to develop HPB surgery as one of the 3 clinical themes. To facilitate this, strong links will be fostered with national professional associations, including our key strategic partner (RCS Engl.) and the specialty societies (AUGIS, GBIHPBA, British Transplantation Society (BTS), Pancreatic Society, and Association of Laparoscopic Surgeons of GB&I (ALSGBI). Engagement with professional societies will enable the MIC to expand its membership, disseminate outputs, and influence national policy. We will establish a strong national identity by working closely with national associations, facilitated through joint promotion of events, contribution to newsletters, reciprocal links to websites, and representation at national meetings. In keeping with MIC philosophy of engaging with the younger innovation community, we will form strong links with national trainee forums, including AUGIS, the national society for trainee HPB surgeons, and the RCS National Research Collaborative, a national network for surgical trainees undertaking collaborative research. We will contribute to the MIC Young Innovators programme and its links to the NHS Clinical Entrepreneurs Training Programme. Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. Through our programme of networking events we will bring together partners from HPB surgery, academia, industry, and PPI to identify new areas for technological development (Innovation cycle: stage 1). We will seek to extend the reach of the MIC, building on the Hub-Spoke model, and stimulating research through our connections to other academic institutes, including Liverpool (Pancreas) and Birmingham (Liver and Transplantation) (Innovation cycle: stage 2). We will focus on areas strength, developing projects with the MIC supporting work streams in physics and engineering, clinical trials, health economics research, pathology, and business development and commercialisation. We will ensure that PPI is well represented in project development, drawing on our work in PROMs investigating quality of life following liver transplantation. Our collaborative work with the RCS Clinical Effectiveness Unit will provide valuable information on areas of inequality and unmet clinical need on a national level Objective 3: accelerating the pull through of early technologies into clinical practice. We will use the expertise in the supporting work streams, and our extensive contacts with academia and industry, to progress projects smoothly through the innovation cycle towards commercialisation and adoption. We will contribute to the MIC Surgical Test Bed (Innovation cycle: step 3) bringing technologies in need of timely clinical evaluation e.g. PINPOINT flourescence imaging for safe gall bladder surgery, EMI-137® fluorescence probe for image-guided liver and pancreatic cancer resection(Edinburgh Molecular Imaging), Geko device for DVT prophylaxis, and liver sealant to reduce blood loss (Purstat study). We will facilitate national engagement in clinical trials (Innovation cycle: step 4) through the Leeds RCS STC, RCS STEPS (Surgical Technologies Evaluation Portal) programme, and RCS National Research Collaborative. Key deliverables: i) HPB established as a MIC clinical theme with strong links to professional associations ii) networking events to identify unmet clinical needs in HPB disease, iii) Young Innovators programme linking to vascular organisations, iv) recruitment of colorectal patients to the MIC Surgical Test Bed. Measures of success: i) identification of 10 unmet clinical need iii) contribution to 4 networking events and 1 MIC National meeting, iii) 4 new projects, 2 with pumppriming, iv) 100 HPB patients recruited to phase I and II industry-led clinical studies. Medium term objectives (years 2 & 3) Objective 1: growing the MIC as the premier national network for Surgical Technologies We will continue to engage with other NIHR infrastructure (Leeds MIC In vitro diagnostics, NOCRI, other MICs) and MedTech organisations (ASHNs, Medilink, KTN network) to mutual advantage. RCS Engl. and the specialist societies, AUGIS and GBIHPBA will be key partners in establishing national identity and engaging with the wider HPB and allied professional communities. Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. We will work to grow the MIC network through its Hub and Spoke model, drawing in other centres of excellence in HPB surgery. We will build on our platform technologies in Leeds, supported by our local charity, “Ray of Hope” and LTHT Charitable Foundation. Current projects include microbubble delivery of therapeutics for hepatobiliary cancer, the role of preoperative “warm up” in improving surgical performance, tissue and fluid metabolomics to identify novel biomarkers of HPD disease, and DCE-MRI imaging to predict liver regeneration following major resection. There are close collaborations with Institute of Biomedical Engineering (IBME), UoL, investigating decellularisation liver technologies to build functioning liver grafts. The Leeds HPB team includes several leading figures in liver and pancreatic surgery (G Toogood, P Lodge, K Prasad, S Pollard) with high representation on national professional associations. They will serve as advocates for the MIC through the various associations. We will engage will PPI groups to better define the unmet needs in HPB surgery e.g. safer surgery for benign biliary disease, improved pancreatic cancer diagnostics, and effective interventions for recurrent pancreatitis. Objective 3: accelerating pull through of surgical technologies into clinical practice. We will continue to work with the MIC Surgical Test Bed, linking with SMEs and multi-national companies to provide access to early clinical evaluation within the NHS (Innovation cycle: step 3). We will work closely with Leeds RCS STC, surgical specialist societies (AUGIS and GBIHPBA), and other clinical networks (NIHR CRN) to develop multicenter clinical validation studies and facilitate patient recruitment (Innovation cycle: step 4), and the MIC Young Innovators Programme to encourage innovation and research at an early stage of clinical training. Key deliverables: i) HPB MIC theme with national profile and strong links to RCS England, AUGIS and GBIHPBA, ii) generation of new technologies to areas of unmet clinical need in HPB surgery, iii) expansion of the MIC Young Innovators programme in HPB surgery, iii) recruitment of HPB patients to the MIC Surgical Test Bed. Measures of success: i) contribution to >10 networking events and 3 MIC National meetings, ii) >12 projects initiated or completed, iii) 5 new technologies evaluated, iv) >500 patients recruited to clinical trials, vi) >£2 million in external research income and >£6 million leveraged income.Long term objectives (year 4) Objective 1: consolidation of a mature MIC infrastructure Year 4 will see the HPB theme fully contributing to the MIC network, providing a pipeline of new technologies through its academic collaborations and industry partners, and contributing to the recruitment of patients to clinical efficacy and validation studies. We will use our PPI groups, and links to professional and allied health associations, to showcase the achievements of the MIC and foster awareness of the new technologies developed and evaluated (Innovation cycle: step 5). The HPB theme will make a full contribution to the sustainability of the MIC network so as to secure its viability beyond the 4-years of funding. It will be a key component of the MIC’s engagement strategy with the wider NHS and MedTech economy. Key deliverables: i) a mature MIC HPB theme with national reach and impact, ii) a portfolio of innovative research projects, supported by external grant income, iii) a pipeline of new colorectal technologies awaiting clinical evaluation, iv) established lines of communication to HPB PPI, Professional Associations, and NHS Commissioning Groups for wider dissemination and adoption. Measures of success: i) engagement with 100 SMEs and multinational companies, ii) 20 active or completed projects, iii) 8 new technologies evaluated, iv) recruitment of >1,000 patients to clinical trials, v) > £4 million in external research income and >£10 million leverage income.


Research activity codes: 8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: ORAL AND GASTROINTESTINAL