Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

N/ACompletedNCT02041871

Assistance Publique - Hôpitaux de Paris399 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

399

Conditions

Hepatectomy Elective Hepatectomy Malignant Tumors

Interventions

Oral immunonutritionDIETARY_SUPPLEMENT

Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

PlaceboDIETARY_SUPPLEMENT

Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Villejuif, France

Outcomes

Primary Outcomes

Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN

Time frame: In the first 30 postoperative days after Liver surgery

Secondary Outcomes

Length of hospital stay

Time frame: 30 days after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.