Elective Hepatectomy, Hepatectomy, Malignant Tumors
Conditions
Keywords
Liver Surgery, Hepatectomy, Immunonutrition, Cancer, Morbidity, Postoperative complication
Brief summary
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.
Detailed description
Perioperative immunonutrition has been developed to improve the immuno metabolic host response and outcome in postoperative period and has been proven to be beneficial in reducing significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. To date, the effects of preoperative oral immunonutrition (ORAL IMPACT) in non cirrhotic patients undergoing liver resection for cancer are unknown. The purpose of this study is to determine whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for malignant tumours.
Interventions
DIETARY_SUPPLEMENTOral immunonutrition
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
DIETARY_SUPPLEMENTPlacebo
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
Sponsors
Nestlé Foundation
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Non cirrhotic patient * Elective liver surgery for cancer (primary or secondary malignant tumours) * Hepatectomy including at least 1 segment or 3 wedge resections
Exclusion criteria
* Liver resection for benign lesions * Liver resection associated with biliary tract surgery * Liver resection associated with gastro-intestinal surgery * Cirrhosis, defined by transient elastography (Fibroscan®) or by liver biopsy * Renal failure * Pregnancy or nursing women * History of hypersensitivity or allergy to arginine, omega-3 fatty acids, or nucleotides * Inability to take oral nutrition * Mental condition rendering the subject unable to understand the nature, end-points and consequences of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN | In the first 30 postoperative days after Liver surgery |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay | 30 days after surgery |
Countries
France
Outcome results
None listed