Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

Not Applicable

Completed

• Conditions: Elective Hepatectomy; Malignant Tumors; Hepatectomy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Oral immunonutrition

• Registration Number: NCT02041871
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Status Verified: 2018-02
• Primary Completion: 2018-09-13
• Study Completion: 2018-09-13
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Impact control	Oral immunonutrition	ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Length of hospital stay	30 days after surgery

Trial Locations

Locations (1)

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire; 🇫🇷 Villejuif, France