Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

Study Overview
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Brief Summary
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To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.

Detailed Description
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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.

Official Title
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Interest of Preoperative Immunonutrition in Liver Resection for Cancer

Conditions
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Hepatectomy, Elective Hepatectomy, Malignant Tumors

Intervention / Treatment
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* Dietary Supplement: Oral immunonutrition
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impact control<br>ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery | Dietary Supplement: Oral immunonutrition<br>* Powder 74g within 250ml of water, 3 times per day during 7 days before surgery<br>* Other names: ORAL IMPACT;|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Powder 74g within 250ml of water, 3 times per day during 7 days before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Surgery, Hepatectomy, Immunonutrition, Cancer, Morbidity, Postoperative complication