MedTrace Logo

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

NCT00151671 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-02-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Novartis

    collaborator INDUSTRY

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Yannick Mallédant, MD · Rennes University Hospital

  • Eric Bellissant, MD, PhD · Rennes University Hospital

  • Philippe Seguin, MD · Rennes University Hospital

  • Karim Boudjema, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2008-04-30
Completion
2008-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00151671 on ClinicalTrials.gov