Authors
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Assoc. Prof. Lindsay Plank -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2012
INTERVENTION: Patients will be randomised to either preoperative supplemental nutrition with IMPACT (Nestle) or to standard care (usually, no supplementation). Patients randomized to the treatment arm will be provided with a prescription for IMPACT and instructions on intake. They will be asked to consume 3 x 237 ml tetra packs daily (1000 kcal providing 12.6 g arginine and 3.3 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), in addition to their usual intake of their normal meals and snacks, for the 5 consecutive days immediately preceding day of surgery. CONDITION: Patients with liver cancer requiring resection PRIMARY OUTCOME: Postoperative immune and inflammatory status which includes C‐reactive protein, total lymphocytes, CD3, CD4, CD8, tumor necrosis factor‐alpha (TNF‐alpha) and interleukin‐6 (IL‐6). These will be assessed on blood samples by ELISA (cytokines), flow cytometry (CD3,4,8), and standard laboratory techniques (CRP, lymphocytes). SECONDARY OUTCOME: Change in total body protein as measured by neutron activation scanning. Ischaemia‐reperfusion injury to the liver assessed on biopsied tissue taken at surgery from the resected liver by measuring mitochodrial function and oxidative stress. Antioxidant status, as it pertains to mitochondrial function, will be determined using TBARS (thiobarbituric acid reactive substances) as an index of lipid peroxidation and oxidative stress in tissue samples. Reactive oxygen species determination will be performed and markers of damage (for example protein carbonyls, lipid peroxides etc) assessed using commercially available kits. Mitochondrial respiration flux will be determined using a high resolution respirometry oxygraph (OROBOROS Oxygraph 2K, Anton paar, Graz, Austria) with a substrate inhibitor protocol that allows rapid analysis of respiratory chain function and integrity in tissue homogenates obtained from the liver sample. Postoperative infectious complications (for example, wound infection, urinary tract infection, pneumonia). These will be assessed usng bedside chart review according to relevant signs and symptoms, positive cultures and whether antibiotic treatment is prescribed. INCLUSION CRITERIA: Scheduled for hepatic resection of primary or secondary liver cancer
Epistemonikos ID: 59eaf37a4f5db73eeb2eb0ca037e25412b681cb9
First added on: Aug 22, 2024