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

Hepatocellular Carcinoma Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151671
• Other study ID #: AFSSAPS 21541
• Secondary ID: PHRC/02-10CIC020
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: February 24, 2012
• Start date: April 2003
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: September 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Cirrhosis
• Liver Fibrosis
• Liver Neoplasms

Intervention

Drug:
• Oral Impact®
Oral nutritional supplement containing L-arginin, ?3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
• Placebo
Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Locations

Country	Name	City	State
France	Service de Réanimation Chirurgicale - Hôpital Pontchaillou	Rennes

Sponsors (3)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France, Novartis

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factor V at day 3 after surgery		day 3	No
Secondary	Liver regeneration kinetics (bile production at days 1, 3, 5 and 7;factor V, ?-glutathione transferase, a-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	No
Secondary	Immunological biomarkers		Within 30 days	No
Secondary	Infections		Within 30 days	No