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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Factor V at day 3 after surgery
day 3
No
Yannick Mallédant, MD
Study Director
Rennes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
AFSSAPS 21541
NCT00151671
April 2003
September 2008
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