Clinical trial · Interventional
Phase II Trial of Immunonutrition in Hepatectomy
Impact of Immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors: A Randomized Controlled Phase II Trial
NCT07395635CI-TRIAL-00102815recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomised open labelled study to evalaute the impact of immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASA I-III Patients | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunonutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Immunomax® Powder- Participant in this group will receive Immunomac Powder 7 consecutive days preceding surgery in a dose of 6-9 scoops (120-180g per day), based on their bodyweight.
- interventionNames
- Dietary Supplement: Immunonutrition
- type
- NO_INTERVENTION
- label
- Standard Arm
- description
- Participant in this group will be advised to continue with their usual oral intake. Patients in this group assessed as having malnutrition will be provided with a standard nutritional supplement (Fortisip®, Nutricia) twice daily (providing 600 kcal energy, 24 g protein), in addition to their usual intake, for the period preceding and including 7 days prior to surgery
Primary outcomes (1)
- measure
- Preoperative immunonutrition improves prognostic nutritional index (PNI)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 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
References
Publications (10)
- RESULTZhang H, Li D, Li J. Prognostic significance of preoperative prognostic nutritional index in hepatocellular carcinoma after curative hepatectomy: a meta-analysis and systemic review. Front Nutr. 2024 Dec 23;11:1433528. doi: 10.3389/fnut.2024.1433528. eCollection 2024. PMID 39764415
- RESULTSolanki SL, Kaur J, Gupta AM, Patkar S, Joshi R, Ambulkar RP, Patil A, Goel M. Cancer related nutritional and inflammatory markers as predictive parameters of immediate postoperative complications and long-term survival after hepatectomies. Surg Oncol. 2021 Jun;37:101526. doi: 10.1016/j.suronc.2021.101526. Epub 2021 Feb 4. PMID 33582497
- RESULTZhang C, Chen B, Jiao A, Li F, Wang B, Sun N, Zhang J. The benefit of immunonutrition in patients undergoing hepatectomy: a systematic review and meta-analysis. Oncotarget. 2017 Aug 8;8(49):86843-86852. doi: 10.18632/oncotarget.20045. eCollection 2017 Oct 17. PMID 29156839
- RESULTWong CS, Praseedom R, Liau SS. Perioperative immunonutrition in hepatectomy: A systematic review and meta-analysis. Ann Hepatobiliary Pancreat Surg. 2020 Nov 30;24(4):396-414. doi: 10.14701/ahbps.2020.24.4.396. PMID 33234742
- RESULTGao B, Luo J, Liu Y, Zhong F, Yang X, Gan Y, Su S, Li B. Clinical Efficacy of Perioperative Immunonutrition Containing Omega-3-Fatty Acids in Patients Undergoing Hepatectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2020;76(6):375-386. doi: 10.1159/000509979. Epub 2020 Dec 11. PMID 33311018
- RESULTBeevi Ss S, Pottakkat B. Effect of Immunonutrition on the Liver Function Status of End-Stage Liver Disease Patients Waiting/Referred for Liver Transplant: A Randomized Controlled Trial. Cureus. 2023 Mar 30;15(3):e36923. doi: 10.7759/cureus.36923. eCollection 2023 Mar. PMID 37128515
- RESULTZhang G, Zhao B, Deng T, He X, Chen Y, Zhong C, Chen J. Impact of perioperative immunonutrition on postoperative outcomes in pancreaticoduodenectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Gastroenterol. 2024 Nov 16;24(1):412. doi: 10.1186/s12876-024-03510-6.