A feasibility multi-centre randomised controlled trial to test if a pre-operative 2-week very low-calorie diet reduces intra-operative blood loss and improves postoperative outcomes following liver surgery, compared with a control group: Reducing Steatosis prior to Liver Resection (RESOLVE)

niversity Hospitals Plymouth NHS Trust0 sites72 target enrollmentMarch 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

March 20, 2023

End Date

March 31, 2025

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals Plymouth NHS Trust

•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

•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 \<20 kg/m²)
•7\. Patients who are lactose intolerant
•8\. Patients who follow a vegan diet
•9\. Patients who report unintentional weight loss of \>5% in 0\-3 months or \>10% in up to 6 months