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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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:


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
Experimental: 1
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.
Placebo Comparator: 2
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:
Responsible Party: Direction of Clinical Research and Strategy, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00151671     History of Changes
Other Study ID Numbers: AFSSAPS 21541, PHRC/02-10, CIC0203/012
Study First Received: September 8, 2005
Last Updated: February 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Carcinoma
Fibrosis
Liver Cirrhosis
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma

ClinicalTrials.gov processed this record on April 17, 2014