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

Phase 2

Terminated

• Conditions: Liver Cancer; Hepatocellular Carcinoma; Cirrhosis; Liver Fibrosis
• Interventions: Drug: Oral Impact®; Drug: Placebo

• Registration Number: NCT00151671
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2008-04
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oral Impact®	Perioperative Oral Nutritional Supplementation
2	Placebo	Placebo of Perioperative Oral Nutritional Supplementation

Primary Outcome Measures

Name	Time	Method
Factor V at day 3 after surgery	day 3

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Réanimation Chirurgicale - Hôpital Pontchaillou; 🇫🇷 Rennes, France