Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer (PROPILS)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hepatectomy; Malignant Tumors; Elective Hepatectomy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oral immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02041871

P120207

Details and patient eligibility

About

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

Full 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.

Enrollment: 399 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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399 participants in 2 patient groups, including a placebo group

Impact control

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral immunonutrition

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo