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


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General Topics A-Z

Cirrhosis

Cirrhosis (Primary Biliary); Cirrhosis of the Liver; Liver Cirrhosis 



Clinical Trial: Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer.

This study is currently recruiting patients.
Verified by Rennes University Hospital September 2005

Sponsors and Collaborators: Rennes University Hospital
French Ministry of Health
Novartis
Information provided by: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00151671

Purpose

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.
Condition Intervention Phase
Liver Cancer
Hepatocellular Carcinoma
Cirrhosis
Liver Fibrosis
  Drug: Oral Impact®
 Phase II
Phase III

MedlinePlus related topics:  Cirrhosis;   Liver Cancer

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Factor V at day 3 after surgery
Secondary Outcomes: 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
Expected Total Enrollment:  50

Study start: April 2003

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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 dilatation

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00151671

Yannick Mallédant, MD      33-2-9928-4246    yannick.malledant@chu-rennes.fr
Eric Bellissant, MD, PhD      33-2-9928-9200    eric.bellissant@chu-rennes.fr

France
      Service de Réanimation Chirurgicale - Hôpital Pontchaillou, Rennes,  35033,  France; Recruiting
Yannick Mallédant, MD  33-2-9928-4246    yannick.malledant@chu-rennes.fr 
Philippe Seguin, MD,  Principal Investigator
Karim Boudjema, MD, PhD,  Principal Investigator
Yves Gandon, MD,  Sub-Investigator
Gilbert Semana, MD,  Sub-Investigator

Study chairs or principal investigators

Yannick Mallédant, MD,  Study Director,  Rennes University Hospital   
Eric Bellissant, MD, PhD,  Study Chair,  Rennes University Hospital   
Philippe Seguin, MD,  Principal Investigator,  Rennes University Hospital   
Karim Boudjema, MD, PhD,  Principal Investigator,  Rennes University Hospital   

More Information

Publications

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.

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.

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.

Study ID Numbers:  AFSSAPS 21541; PHRC/02-10; CIC0203/012
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00151671
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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