Support healthy liver. Image courtesy of GettyImages
RESOLVE is a NIHR funded feasibility Randomised Controlled Trial developed to investigate the effects of a two-week very low-calorie diet (VLCD) plus dietetic support intervention for patients with hepatic steatosis (HS) before elective liver surgery (LS). The study is led by Mr Somaiah Aroori (Consultant Hepatico Pancreato Biliary & Transplant Surgeon) and Professor Victoria Allgar (Professor of Medical Statistics and Director of PenCTU). The study is managed by the Peninsula Clinical Trials Unit
Hepatic steatosis (fatty liver) is now the most common liver disorder affecting between 20-50% of the Western population. HS increases morbidity and mortality associated with LS. The morbidity rates of LS range from 22-62% in the presence of steatosis compared to 8-35% in patients without steatosis. Reported mortality for LS in patients with moderate to severe steatosis is 14% compared with 3% in patients without steatosis. Furthermore, patients with steatosis are more likely to require a blood transfusion, which is associated with worse short- and long-term outcomes.
At present, patients with HS requiring LS receive no specific dietary treatment or advice. VLCD is commonly used for 2-12 weeks before gallbladder and bariatric surgery to reduce liver volumes and reduce associated intraoperative morbidity. However, there is a lack of scientific evidence on whether these diets would be useful in patients with HS undergoing LS.
This feasibility study aims to obtain the data and gain the experience required to inform and finalise the design of a definitive RCT. This will provide high-quality data to estimate screening rates, recruitment, randomisation, retention and intervention adherence. The study will also determine the most clinically relevant primary outcome for the definitive trial. The study will also estimate resource use and costs associated with the delivery of the intervention and assess the feasibility of undertaking a cost-effectiveness analysis alongside a full trial.
Seventy-two patients with HS who are scheduled for LS from four sites will be randomly allocated to receive either a 2-week VLCD plus support intervention or usual care, which may include healthy eating advice. The VLCD will consist of 4 sachets/day of a liquid meal replacement, providing up to 850 kcals and 78g protein plus low starch vegetables. Surgical outcomes will be collected. Focus groups and qualitative interviews will provide information about participants' experiences in the trial and the intervention.
A group of patients who have previously experienced this surgical pathway or have had the experience of VLCD have advised on the plan of investigation and the intervention.
The study opened in University Hospitals Plymouth NHS Trust in May 2023 and will be collecting data for 12 months.