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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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