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 个研究点目标入组 72 人开始时间: 2023年3月20日最近更新: 2024年7月8日

适应症

试验速览

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•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

发起方

niversity Hospitals Plymouth NHS Trust