Liver surgery Surgery
Conditions
Interventions
In the future definitive trial, the primary research question will be: In patients with a diagnosis of hepatic steatosis (fatty liver) who are having elective liver surgery, does VLCD with dietitian e
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients =18 years 2. Able to provide informed consent 3. Patients with hepatic steatosis (fatty liver) with or without non-alcohol steatohepatitis (NASH) requiring liver resection 4. Patients selected for liver resection surgery for treatment of metastases, hepatocellular carcinoma, gallbladder cancer, peripheral cholangiocarcinoma, or pre-malignant hepatic tumours
Exclusion criteria
Exclusion criteria: 1. Patients with normal background liver on pre-op MRI 2. Patients with cirrhosis with or without signs of portal hypertension 3. Pregnant women 4. Patients that cannot tolerate low fat diet or are allergic or intolerant to components of VLCD sachets 5. Patients who are unable to complete a food diary 6. Patients who are underweight (BMI 5% in 0-3 months or >10% in up to 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a future definitive trial, assessed using: 1. Rates of screening at MDT meeting, recruitment at consent, and randomisation numbers (as a proportion of patients screened) at randomisation 2. Retention measured as the number of patients completing measures on the day of surgery and the number of patients completing the food diary over the period of VLCD 3. Adherence to VLCD and study requirements prior to liver surgery and any possible contamination assessed by measuring changes in body weight, food diary reports and numbers of empty sachets returned pre-operatively. In addition, qualitative interviews and focus groups will explore further at 1-month post-surgery 4. Completeness of data collection measured at baseline, day of surgery plus 30- and 90-days postoperatively 5. Preliminary assessment of the VLCD intervention by audio recording some of the intervention sessions at the start of the recruitment period, halfway through and nearer the end. Also feedback is obtained from qualitative interviews with staff delivering the intervention post-recruitment. 6. Resource use and costs associated with the delivery of the intervention, and pilot methods for the cost-effectiveness framework in a full trial using the EuroQoL 5-Dimension 5 level (EQ-5D-5L) at baseline, day of surgery, 30 and 90 days postoperatively and a bespoke Resource Use Questionnaire at 30 and 90 days postoperatively 7. Identify if there is a need to modify the VLCD and its delivery within the NHS and if so, methods for improvement including exploring barriers and facilitators to delivering the intervention in focus groups with staff post recruitment and qualitative work with the participants post-surgery 8. Identify the most clinically relevant primary outcome for the definitive trial: operating time, ease of liver surgery, blood loss, blood transfusion requirement, time to functional recovery, Comprehensive Complications Index (CCI), overall Clavien-Dindo grade I-V postoperative comp | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures that will be evaluated within this feasibility study are as follows: 1. Surgical outcomes: 1.1. Intra-operative blood loss, blood transfusion requirements, duration of surgery (in minutes), and ease of liver surgery measured using a subjective measure of 1 to 5 peri-operatively 1.2. Intra-operative complications assessed using Clavien-Dindo grade III (bleeding, injury to surrounding structures, cardiovascular events, cerebrovascular events, anaesthetic-related complications) 1.3. Length of stay (in days), postoperative complications (CCI score), readmission rate and mortality within 30 and 90 days, overall, in-hospital blood transfusion requirements measured in units postoperatively 2. Time to functional recovery measured using the number of days between surgery and the date of proposed discharge Patient-reported and other clinical outcomes will be measured: 1. Total energy and protein intake measured by self-report in diary (number of sachets per day + any additional food/fluids consumed) over the 2-week preoperative period 2. Weight and hand grip strength measured using a hand grip dynamometer pre and post diet 3. Mood assessed using a self-report four-point scale in the diary daily over the 2-week diet period 4. Side effects of VCLD assessed using self-report to the research team at any point during the diet 5. Health-related quality of life measured using the EuroQoL 5-Dimension 5 level (EQ-5D-5L) at baseline, day of surgery, 30 and 90 days postoperatively 6. Use of health, social care and wider societal resources measured using a bespoke Resource Use Questionnaire at 30 and 90 days postoperatively | — |
Countries
England, United Kingdom
Outcome results
None listed