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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Hepatocellular Carcinoma, Cirrhosis, Liver Fibrosis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Factor V at day 3 after surgery

Outcome Time Frame:

day 3

Safety Issue:

No

Principal Investigator

Yannick Mallédant, MD

Investigator Role:

Study Director

Investigator Affiliation:

Rennes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AFSSAPS 21541

NCT ID:

NCT00151671

Start Date:

April 2003

Completion Date:

September 2008

Related Keywords:

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Cirrhosis
  • Liver Fibrosis
  • Surgery
  • Liver Cancer
  • Cirrhosis
  • Nutrition
  • Carcinoma
  • Fibrosis
  • Liver Cirrhosis
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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