Impact of immunonutrition in patients undergoing hepatectomies for liver tumors: A randomized controlled phase II trial.

Abstract

TPS4259 Background: Recent studies have demonstrated that immunonutrition has the potential to improve the host immune state, reduce infectious complications, and shorten the length of hospital stay after major abdominal surgeries. Controversy still persists regarding whether or not perioperative immunonutrition could offer substantial benefits to patients undergoing hepatectomy as compared with standard nutrition. Several biomarker-based indices reflecting the immune as well as nutritional status, have been investigated, to predict postoperative morbidity following major hepatectomies. One such index, validated in a meta-analysis is the prognostic nutritional index (PNI). Prognostic Nutritional Index (PNI) = [(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)], with higher PNI correlating with improved survival outcomes . Based on this we aim to conduct a randomized controlled trial to evaluate the improvement of PNI, by immunonutritional intervention in patient undergoing major hepatectomies. Methods: Study Design: Open labelled, Phase II randomized controlled trial. Eligibility criteria: Inclusion: (1) Patients with liver tumors planned for major hepatectomies (defined as resection of >/= 3 liver segments); (2) Age above 18 years; (3) ASA class I-III. Exclusion: (1) Preoperative severe renal failure (estimated glomerular filtration rate < 30 ml/min); (2) History of hypersensitivity to arginine, omega-3 fatty acids, or nucleotide; (3) Inability to take oral nutrition; (4) Pregnancy; (5) Mental condition rendering the subject unable to understand the nature, endpoints and consequences of the trial. Interventions: Randomization will be carried out centrally at the Clinical Research Secretariat, Tata Memorial Hospital. The trial statistician will generate a permuted-block randomization sequence using variable sized blocks of 2, or 4, without any stratification factors. Participants will be randomly assigned in 1:1 to receive either the intervention or control. Details of Intervention: In addition to their usual intake, patients in the intervention arm will be prescribed for each of the 7 consecutive days preceding surgery 6-9 scoops Immunomax powder (120-180g per day), based on weight. At recruitment, blood samples will be taken for inflammatory and immune status markers. These measurements will be repeated on the day prior to surgery (D-1) and on POD 1, 3, 5 and 7. An additional Creactive protein (CRP) measurement will be taken on POD30. PNI will be calculated before the intervention and on the day prior to surgery. Primary Endpoints: Mean difference in PNI points between intervention and control group. Secondary Endpoints: (1) Incidence of postoperative complication; (2) Incidence of post-hepatectomies liver failure (PHLF); (3) Length of ICU stay; (4) Length of hospital stay; (5) Incidence of 90 days mortality. 100 patients will be enrolled over 2 years. Clinical trial information: CTRI/2025/06/088908.