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

NCT ID: NCT00151671

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-09-30

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.

Conditions

Liver Cancer; Hepatocellular Carcinoma; Cirrhosis; Liver Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Perioperative Oral Nutritional Supplementation

Group Type: EXPERIMENTAL

Oral Impact®

Intervention Type: DRUG

Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

2

Placebo of Perioperative Oral Nutritional Supplementation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Interventions

Oral Impact®

Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Intervention Type: DRUG

Placebo

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rennes University Hospital

Principal Investigators

Yannick Mallédant, MD

Role: STUDY_DIRECTOR

Rennes University Hospital

Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

Rennes University Hospital

Philippe Seguin, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Karim Boudjema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Service de Réanimation Chirurgicale - Hôpital Pontchaillou

Rennes, , France

Countries

France

References

Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701. doi: 10.1016/s0140-6736(01)05836-6.

Reference Type: BACKGROUND

PMID: 11551575 (View on PubMed)

Senkal M, Zumtobel V, Bauer KH, Marpe B, Wolfram G, Frei A, Eickhoff U, Kemen M. Outcome and cost-effectiveness of perioperative enteral immunonutrition in patients undergoing elective upper gastrointestinal tract surgery: a prospective randomized study. Arch Surg. 1999 Dec;134(12):1309-16. doi: 10.1001/archsurg.134.12.1309.

Reference Type: BACKGROUND

PMID: 10593328 (View on PubMed)

Braga M, Gianotti L, Radaelli G, Vignali A, Mari G, Gentilini O, Di Carlo V. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999 Apr;134(4):428-33. doi: 10.1001/archsurg.134.4.428.

Reference Type: BACKGROUND

PMID: 10199318 (View on PubMed)

Other Identifiers

PHRC/02-10

Identifier Type: -

Identifier Source: secondary_id

CIC0203/012

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 21541

Identifier Type: -

Identifier Source: org_study_id