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

This study has been terminated.
Study NCT00151671.   Last updated on September 30, 2008.   Information provided by Rennes University Hospital

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Descriptive Information Fields
Brief Title  Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer
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
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 Phase Phase II, Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Factor V at day 3 after surgery [ Time Frame: day 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 [ Time Frame: days 1, 3, 5, 7, 10 and 30 ] [ Designated as safety issue: No ]
Immunological biomarkers [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Infections [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Condition  Liver Cancer
Hepatocellular Carcinoma
Cirrhosis
Liver Fibrosis
Intervention  Drug: Oral Impact®
Drug: Placebo
MEDLINE PMIDs 11551575,   10593328,   10199318
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  35
Start Date  April 2003
Completion Date September 2008
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  France
Administrative Information Fields
NCT ID  NCT00151671
Organization ID AFSSAPS 21541
Secondary IDs †† PHRC/02-10, CIC0203/012
Study Sponsor  Rennes University Hospital
Collaborators †† Ministry of Health, France
Novartis
Investigators 
Study Director:     Yannick Mallédant, MD     Rennes University Hospital    
Study Chair:     Eric Bellissant, MD, PhD     Rennes University Hospital    
Principal Investigator:     Philippe Seguin, MD     Rennes University Hospital    
Principal Investigator:     Karim Boudjema, MD, PhD     Rennes University Hospital    
Information Provided By Rennes University Hospital
Verification Date September 2008
First Received Date  September 8, 2005
Last Updated Date September 30, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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