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

This study is currently recruiting participants.
Verified by Rennes University Hospital, May 2007

Sponsors and Collaborators: Rennes University Hospital
Ministry of Health, France
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:   Cancer    Cirrhosis    Dietary Supplements    Liver Cancer   

U.S. FDA Resources

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 as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Factor V at day 3 after surgery [ Time Frame: day 3 ]

Secondary Outcome Measures:
  • 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 ]
  • Immunological biomarkers
  • Infections

Estimated Enrollment:   50
Study Start Date:   April 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151671

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

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

Sponsors and Collaborators
Rennes University Hospital
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    
  More Information

Publications:

Study ID Numbers:   AFSSAPS 21541, PHRC/02-10, CIC0203/012
First Received:   September 8, 2005
Last Updated:   May 7, 2007
ClinicalTrials.gov Identifier:   NCT00151671
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:
Surgery  
Liver Cancer  
Cirrhosis  
Nutrition  

Study placed in the following topic categories:
Liver Diseases
Hepatic fibrosis
Digestive System Neoplasms
Carcinoma, Hepatocellular
Fibrosis
Liver neoplasms
Liver Cirrhosis
Carcinoma
Liver Neoplasms
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 05, 2008




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