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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.
(insufficient enrollment rate)
Sponsor:
Collaborators:
Ministry of Health, France
Novartis
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151671
First received: September 8, 2005
Last updated: February 24, 2012
Last verified: September 2008

September 8, 2005
February 24, 2012
April 2003
April 2008   (final data collection date for primary outcome measure)
Factor V at day 3 after surgery [ Time Frame: day 3 ] [ Designated as safety issue: No ]
Factor V at day 3 after surgery
Complete list of historical versions of study NCT00151671 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1) 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
  • 2) Immunological biomarkers
  • 3) Infections
Not Provided
Not Provided
 
Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Cirrhosis
  • Liver Fibrosis
  • Drug: 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.
  • Drug: Placebo
    Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
  • Experimental: 1
    Perioperative Oral Nutritional Supplementation
    Intervention: Drug: Oral Impact®
  • Placebo Comparator: 2
    Placebo of Perioperative Oral Nutritional Supplementation
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
September 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00151671
AFSSAPS 21541, PHRC/02-10, CIC0203/012
No
Direction of Clinical Research and Strategy, Rennes University Hospital
Rennes University Hospital
  • Ministry of Health, France
  • Novartis
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
Rennes University Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP