Image guided laparoscopic liver resection: a feasibility randomised controlled trial

Research question : The feasibility of a randomised controlled trial comparing the SmartLiver system of image guided liver surgery versus standard care in laparoscopic liver surgery.

Background The laparoscopic approach to liver resection surgery has been demonstrated to be safe and effective in selected cases with level 1 evidence to support its use.

However the uptake of the laparoscopic approach for major liver resections (3 or more liver segments) has been slow due to surgeons anxiety of defining cancer resection margins during laparoscopic surgery and the risk of injury to major vessels and bile ducts in the absence of the ability to palpate the tumour mass.

Our solution was to develop a system in which the pre-operative CT scan of an individual patient is segmented to show individual structures within the liver and their relationship to the cancer being resected.

This individualised 3D model of the liver is then super-imposed on the laparoscopic view of the liver at the time of the laparoscopic liver resection. The system development was funded by the Department of Health (DoH) and Wellcome Trust (WT) .

The system was then further developed for clinical use in the operating theatres and evaluated in a single liver surgery centre (Royal Free Hospital) through an NIHR i4i fund.

Aims and Objectives To determine the feasibility of comparing SmartLiver directed laparoscopic liver surgery with standard laparoscopic liver surgery in 3 seperate UK liver surgery centres. Methods Design: A pragmatic UK 3 centre feasibility randomised controlled trial (RCT).

Eligible patients will be those considered suitable for laparoscopic liver resection surgery in individual centres following review at the centre multidisciplinary team (MDT) meeting and pre-operative assessment..

Eligible patients will be contacted by the research team and fully informed consent obtained for the clinical trial and qualitative evaluation.

Consenting patients will be randomised using the Sealed Envelope randomisation system to : SMARTLiver-guided laparoscopic liver resection (intervention) Minimally invasive liver resection (intervention) guided by the SmartLIver system.

Standard laparoscopic liver resection (control) Minimally invasive liver resection performed using a standardised protocol. End points. Feasibility end points of patient recruitment and withdrawal from the study. Technical feasibility of completion of the image overlay.

Secondary end points will be used to select the primary end point and determine the power of a subsequent study to evaluate the cost effectiveness of the SmartLiver system.

The secondandary end point will be complications, mortality, health-related quality of life, conversion to open surgery, operating time, blood transfusion requirements, length of hospital stay, return to work or normal activities.

Timelines for delivery: 36 months. 4 months pre-award preparation, 6 months completion trial governance and site set up. Recruitment 2-years, follow up 3 months. Data cleaning and analysis 3 months. Anticipated Impact and Dissemination End of study stakeholders event. Results presented at National and International Scientific meetings.

PPI co-applicant will lead dissemination policy to specialist organisations and patient support groups. Subsequent NIHR HTA submission on cost effectiveness of the SmartLiver system. NICE approval, NHS adoption and wider international commercial development.