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

Rennes University Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Cirrhosis; Liver Fibrosis; Hepatocellular Carcinoma; Liver Cancer

Treatments: Drug: Oral Impact®; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00151671

CIC0203/012

AFSSAPS 21541

PHRC/02-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Perioperative Oral Nutritional Supplementation

Treatment:

Drug: Oral Impact®

2

Placebo Comparator group

Description:

Placebo of Perioperative Oral Nutritional Supplementation

Treatment:

Drug: Placebo