Phase II Trial of Immunonutrition in Hepatectomy

February 6, 2026 updated by: Dr Shraddha Patkar, Tata Memorial Centre

Impact of Immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors: A Randomized Controlled Phase II Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Major hepatectomy remains a cornerstone in the curative management of primary and secondary liver tumors. Despite substantial advances in surgical techniques, anesthesia, and perioperative care, hepatectomy continues to be associated with considerable postoperative morbidity and mortality. Reported morbidity rates range from 22% to 40%, while mortality rates vary between 4% and 11%, largely driven by postoperative infectious complications, liver failure, and systemic inflammatory responses. Optimization of preoperative patient status, particularly nutritional and immune function, has therefore emerged as a critical area of interest to improve postoperative outcomes.

Immunonutrition, defined as nutritional supplementation enriched with specific substrates such as arginine, omega-3 fatty acids, and nucleotides, has demonstrated beneficial effects in patients undergoing major gastrointestinal surgery, pancreatic resections, and liver transplantation. These formulations are thought to modulate immune response, attenuate postoperative inflammation, improve protein synthesis, and enhance wound healing. However, evidence supporting the routine use of immunonutrition in patients undergoing hepatectomy remains limited and inconsistent. Existing meta-analyses suggest reductions in postoperative infectious complications and length of hospital stay, but uncertainty persists regarding its overall clinical benefit, particularly in relation to objective nutritional and immunological markers.

The prognostic nutritional index (PNI), calculated using serum albumin levels and total lymphocyte count, is a validated composite marker reflecting both nutritional and immune status. Multiple studies and meta-analyses have shown that a higher preoperative PNI is associated with improved postoperative outcomes and survival following hepatectomy. Furthermore, recent evidence indicates that inflammatory and nutritional biomarkers, including dynamic changes in albumin-based indices, are strong predictors of postoperative morbidity. These findings suggest that targeted immunonutritional interventions capable of improving PNI may translate into meaningful clinical benefits.

Against this background, the present study is designed to evaluate whether preoperative immunonutrition can improve PNI in patients undergoing major hepatectomy for liver tumors. The central hypothesis is that short-term preoperative immunonutrition leads to a measurable improvement in PNI compared with standard nutritional care.

The aim of the study is to assess the effect of preoperative immunonutrition on the prognostic nutritional index in patients planned for major hepatectomy.

The primary objective is to compare the mean change in PNI between patients receiving immunonutrition and those receiving standard nutritional care.

Secondary objectives include evaluating the impact of immunonutrition on postoperative complications, incidence of post-hepatectomy liver failure, length of intensive care unit stay, overall hospital stay, and 90-day postoperative mortality.

This is an open-label, randomized, phase II controlled trial conducted at Tata Memorial Hospital, Mumbai. Adult patients (≥18 years) with liver tumors scheduled for major hepatectomy, defined as resection of three or more liver segments, and classified as ASA physical status I-III will be eligible for inclusion. Patients with severe renal dysfunction, hypersensitivity to immunonutritional components, inability to tolerate oral intake, pregnancy, or conditions impairing informed consent will be excluded.

Eligible patients providing written informed consent will be randomized in a 1:1 ratio into one of two study groups using a centrally generated permuted-block randomization sequence. The intervention group will receive preoperative immunonutrition in addition to their usual oral intake for seven consecutive days prior to surgery. The immunonutritional supplement will be administered in weight-adjusted doses and compliance will be monitored through patient records and telephonic reminders. The control group will continue with their usual oral intake; patients identified as malnourished in this group will receive standard nutritional supplementation as per institutional protocols.

Blood samples will be collected at baseline and repeated on the day prior to surgery to assess serum albumin, lymphocyte count, and inflammatory markers. PNI will be calculated at baseline and preoperatively to evaluate the effect of the intervention. Postoperative assessments will include serial liver function tests, documentation of complications up to 90 days, and recording of ICU and hospital stay durations.

A total of 100 patients (50 per group) will be enrolled over two years, providing adequate power to detect a clinically meaningful difference in PNI between groups. Data will be collected prospectively and analyzed using appropriate statistical methods. Continuous variables will be summarized using means and standard deviations, while categorical variables will be expressed as proportions. The primary endpoint will be analyzed by comparing mean PNI differences between groups, with secondary outcomes evaluated using standard comparative statistical tests.

In summary, this study seeks to generate high-quality prospective evidence on the role of preoperative immunonutrition in improving nutritional and immune status, as measured by PNI, in patients undergoing major hepatectomy. The findings have the potential to inform perioperative nutritional strategies and improve postoperative outcomes in this high-risk surgical population.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Dr. Shraddha Patkar
        • Contact:
        • Principal Investigator:
          • Dr. Shraddha Patkar, MD MCh
        • Sub-Investigator:
          • Dr. Mahesh Goel, MBBS, MD
        • Sub-Investigator:
          • Dr. Sridhar Sundaram, MBBS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
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
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)
Other Names:
  • PENTASURE IMMUNOMAX POWDER
No Intervention: Standard Arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative immunonutrition improves prognostic nutritional index (PNI)
Time Frame: 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)].
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative complications
Time Frame: upto 3 months
number of complications in both arm major with Clavien-Dindo (CD) classification for adverse events 2. Incidence of post-hepatectomies liver failure (PHLF) 3. Length of ICU stay 4. Length of hospital stay, 5. Incidence of 90 days mortality
upto 3 months
Incidence of post-hepatectomies liver failure (PHLF)
Time Frame: Perioperative upto day 5
nuber of patients undergoing hepatice failure in both study arm after the major hepatectomies define by ndicated by elevated total bilirubin (\(>22\ \mu \text{mol/L}\)) and increased INR (\(>1.2\)) on or after the fifth postoperative day (POD 5), as per ISGLS criteria
Perioperative upto day 5
Length of ICU stay
Time Frame: Perioperative upto day 30
number of days participant spent in ICU after hepatectomy till discharge in both treatment group
Perioperative upto day 30
Length of hospital stay,
Time Frame: Perioperative upto day 30
number of days participant spent in hospital after hepatectomy till discharge in both treatment group
Perioperative upto day 30
Incidence of 90 days mortality
Time Frame: Perioperative upto day 90
death of participant from any cause after the hepatecomy in both treatment groups
Perioperative upto day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Investigators

  • Principal Investigator: Dr. Shraddha Patkar, MD MCh, Professor and surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study no: 4783

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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