Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer - Full Text View

Sponsor:	Rennes University Hospital
Collaborators:	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® Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cirrhosis Dietary Supplements Liver Cancer Surgery

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Factor V at day 3 after surgery [ Time Frame: day 3 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Enrollment:	35
Study Start Date:	April 2003
Study Completion Date:	September 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Perioperative Oral Nutritional Supplementation	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.
2: Placebo Comparator Placebo of Perioperative Oral Nutritional Supplementation	Drug: Placebo Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

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

Locations

France
Service de Réanimation Chirurgicale - Hôpital Pontchaillou
Rennes, France, 35033

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:

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.

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	AFSSAPS 21541, PHRC/02-10, CIC0203/012
Study First Received:	September 8, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00151671 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

Surgery
Liver Cancer
Cirrhosis
Nutrition

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Fibrosis
Carcinoma, Hepatocellular
Liver Cirrhosis
Carcinoma

Liver Neoplasms
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009