Immunonutrition for adults undergoing major hepatectomy
Official title: Impact of Immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors: A Randomized Controlled Phase II Trial
Run by Tata Memorial Centre · NCT07395635 · Data updated 2026-11-12
This study will test whether giving immunonutrition supplements around major liver surgery helps adults with liver tumors recover with fewer infections and shorter hospital stays.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Locations | 1 site (Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | October 3, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07395635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (>=18 years) with primary or secondary liver tumors scheduled for a major hepatectomy (>=3 segments), ASA class I–III, who can take oral nutrition and are not pregnant.
✕Probably not a fit
Patients with severe renal failure (eGFR <30 ml/min), known allergy to arginine/omega-3/nucleotides, inability to take oral nutrition, pregnancy, or inability to consent are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label study at Tata Memorial Centre enrolling adults planned for major hepatectomy (resection of >=3 liver segments). Participants will receive an immunonutrition formula containing substrates such as arginine, omega-3 fatty acids, and nucleotides in the perioperative period, compared with standard care. Key outcomes include postoperative infectious complications, length of hospital stay, and changes in nutritional and immunological markers. Patients with severe renal failure, known hypersensitivity to supplement components, inability to take oral nutrition, or pregnancy are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative infections, speed recovery, and shorten hospital stays after major liver resection.
How similar studies have gone: Randomized trials and meta-analyses in major gastrointestinal surgery and liver transplantation have reported reductions in postoperative infections and shorter stays with immunonutrition, but results specific to hepatectomy are limited and inconsistent.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dr. Shraddha Patkar
Mumbai, Maharashtra, India Recruiting
Study contacts
- Principal investigator: Dr. Shraddha Patkar, MD MCh — Professor and surgeon
- Study coordinator: Dr. Shraddha Patkar, MD MCh
- Email: drshraddhapatkar@gmail.com
- Phone: 9820074818
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.