Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer

Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151671

Acronym

IMPACT

Enrollment

Registered

2005-09-09

Start date

2003-04-30

Completion date

2008-09-30

Last updated

2012-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatocellular Carcinoma, Liver Cancer, Liver Fibrosis

Keywords

Surgery, Liver Cancer, Cirrhosis, Nutrition

Brief summary

Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

Detailed description

In patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. These complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. A good preoperative nutritional state has been shown to reduce complications and mortality. This can be amplified by preoperative nutrition with supplements containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. In this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. The aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.

Interventions

DRUGOral Impact®

Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

DRUGPlacebo

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult over 18 years * Hepatectomy of at least 2 segments * For primary or secondary cancer * With cirrhosis (Child Pugh \<8) or liver fibrosis (fibrosis score of 3) * Informed written consent

Exclusion criteria

* Pregnancy * Recent weight loss of more than 10% of body weight * Immunological deficiency * Portal or hepatic arterial thrombosis * Biliary duct dilation

Design outcomes

Primary

Measure	Time frame
Factor V at day 3 after surgery	day 3

Secondary

Measure	Time frame
Liver regeneration kinetics (bile production at days 1, 3, 5 and 7;factor V, γ-glutathione transferase, α-foetoprotein at days 1, 3, 5, 7, 10 and 30; liver volume at days 10 and 30	days 1, 3, 5, 7, 10 and 30
Immunological biomarkers	Within 30 days
Infections	Within 30 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026