Phase II Trial of Immunonutrition in Hepatectomy

NCT07395635 | Recruiting

• 1 other identifier: Study no: 4783
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised open labelled study to evalaute the impact of immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors

Conditions

Hepatocellular Carcinoma; ASA I-III Patients

Keywords

Immunonutrition; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Preoperative immunonutrition improves prognostic nutritional index (PNI)

  improvement in prognostic nutritional index after maor hepatectomies calculated with the help of Prognostic Nutritional Index (PNI) = \[(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)\].

  90 days

Secondary Outcomes (5)

• Incidence of postoperative complications

  upto 3 months

• Incidence of post-hepatectomies liver failure (PHLF)

  Perioperative upto day 5

• Length of ICU stay

  Perioperative upto day 30

• Length of hospital stay,

  Perioperative upto day 30

• Incidence of 90 days mortality

  Perioperative upto day 90

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Dietary Supplement: Immunonutrition

Standard Arm

NO INTERVENTION

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

Interventions

Immunonutrition DIETARY_SUPPLEMENT

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 PENTASURE Immunomax® powder (120-180g per day)

Also known as: PENTASURE IMMUNOMAX POWDER

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with liver tumors planned for major hepatectomies (defined as resection of \>/= 3 liver segments)
• Age above 18 years
• ASA class I-III

You may not qualify if:

• Preoperative severe renal failure (estimated glomerular filtration rate \< 30 ml/min)
• History of hypersensitivity to arginine, omega-3 fatty acids, or nucleotide 3. Inability to take oral nutrition
• \. Pregnancy 5. Mental condition rendering the subject unable to understand the nature, endpoints and consequences of the trial

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Dr. Shraddha Patkar

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (10)

• Zhang 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 RESULT

• Solanki 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 RESULT

• Zhang 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 RESULT

• Wong 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 RESULT

• Gao 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 RESULT

• Beevi 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 RESULT

• Zhang 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.

  PMID: 39550568 RESULT

• Markar S, Mariette C, Bonnetain F, Lundell L, Rosati R, de Manzoni G, Bonavina L, Tucker O, Plum P, D'Journo XB, Van Daele D, Cogill G, Santi S, Farran L, Iranzo V, Pera M, Veziant J, Piessen G. Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial. Dis Esophagus. 2025 Jan 7;38(1):doae113. doi: 10.1093/dote/doae113.

  PMID: 39863958 RESULT

• Franken LC, Schreuder AM, Roos E, van Dieren S, Busch OR, Besselink MG, van Gulik TM. Morbidity and mortality after major liver resection in patients with perihilar cholangiocarcinoma: A systematic review and meta-analysis. Surgery. 2019 May;165(5):918-928. doi: 10.1016/j.surg.2019.01.010. Epub 2019 Mar 11.

  PMID: 30871811 RESULT

• van Keulen AM, Buttner S, Erdmann JI, Hagendoorn J, Hoogwater FJH, IJzermans JNM, Neumann UP, Polak WG, De Jonge J, Olthof PB, Koerkamp BG. Major complications and mortality after resection of intrahepatic cholangiocarcinoma: A systematic review and meta-analysis. Surgery. 2023 Apr;173(4):973-982. doi: 10.1016/j.surg.2022.11.027. Epub 2022 Dec 27.

  PMID: 36577599 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dr. Shraddha Patkar, MD MCh

  Professor and surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shraddha Patkar, MD MCh

CONTACT

9820074818; drshraddhapatkar@gmail.com

Dr Mahesh Goel, MBBS, MD

CONTACT

9820504492; drmaheshgoel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not Applicable open labelled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Surgeon

Model Details: Open labelled, Phase II randomized controlled trial Interventional Study

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 9, 2026
• Study Start: October 3, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)