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

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborators: Ministry of Health, France; Novartis

Criteria

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