CompletedPhase 2Phase 3ACTRN12612001151820

Immunonutrition in liver surgery

Effect of Preoperative Immunonutrition on Outcome in Patients Undergoing Partial Hepatectomy: A Randomised Pilot Study


Sponsor

Assoc. Prof. Lindsay Plank

Enrollment

30 participants

Start Date

Nov 26, 2012

Study Type

Interventional

Conditions

Summary

Immunonutrition enriched in arginine and omega-3 fatty acids (from fish oil) provided as a preoperative supplement to patients undergoing gastrointestinal surgery has been shown to almost halve postoperative infectious complications. To date, this treatment has not been investigated in patients undergoing liver surgery, except in one small study published in a Japanese medical journal. We will randomise patients scheduled for liver resection to an immunonutrition supplement to be taken preoperatively for 5 days or to standard care. Body composition assessments will be performed pre- and post-surgery and patients will be followed for 30 d post-surgery for complications. During liver resection, the liver is rendered ischaemic for a period of time before reperfusion occurs. Liver dysfunction together with mitochondrial dysfunction resulting in oxidative stress and an increased inflammatory reaction is a consequence of this ischaemia-reperfusion injury. This has been demonstrated in animal studies in which arginine and omega-3 acids have been shown to ameliorate the injury. Liver tissue samples will be collected at time of surgery for analysis of mitochondrial function and oxidative stress. The current pilot study is intended to examine the effects of preoperative nutrition with immune-modulatory properties on postoperative outcome in these patients in terms of liver mitochondrial function and oxidative stress, inflammatory response, muscle loss, and complication rates. These data will provide the foundation for a larger scale study with infectious complications as a primary end-point.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria1

  • Scheduled for hepatic resection of primary or secondary liver cancer

Exclusion Criteria7

  • Diabetes
  • Immunosuppression
  • Cirrhosis (biopsy proven or fibroscan result)
  • Chemotherapy within the 3 weeks prior to study entry
  • Taking fish oil supplements
  • Not able to take oral supplements
  • Pregnant or likely to become pregnant during the study period

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Patients will be randomised to either preoperative supplemental nutrition with IMPACT (Nestle) or to standard care (usually, no supplementation). Patients randomized to the treatment arm will be pro

Patients will be randomised to either preoperative supplemental nutrition with IMPACT (Nestle) or to standard care (usually, no supplementation). Patients randomized to the treatment arm will be provided with a prescription for IMPACT and instructions on intake. They will be asked to consume 3 x 237 ml tetra packs daily (1000 kcal providing 12.6 g arginine and 3.3 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), in addition to their usual intake of their normal meals and snacks, for the 5 consecutive days immediately preceding day of surgery.


Locations(1)

Auckland, New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12612001151820