Phase II Trial of Immunonutrition in Hepatectomy

NCT07395635 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Not applicable

Started

2025-10-03

Last updated

2026-02-09

Condition(s) studied

Hepatocellular CarcinomaASA I-III Patients

Investigational drug(s) / intervention(s)

Immunonutrition

Immunonutrition: 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)

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

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

Primary outcome measure(s)

Preoperative immunonutrition improves prognostic nutritional index (PNI) — 90 days
improvement in prognostic nutritional index after maor hepatectomies calculated with the help of Prognostic Nutritional Index (PNI) = \[(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)\].

Trial sites (1)

Facility	City	Region	Status
Dr. Shraddha Patkar	Mumbai	Maharashtra	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395635 on ClinicalTrials.gov ↗ ← All trials in India