PROPILS: Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02041871

Collaborator

Nestlé Foundation (Other)

399

Enrollment

Location

Arms

60.4

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy Elective Hepatectomy Malignant Tumors	Dietary Supplement: Oral immunonutrition Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

399 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Interest of Preoperative Immunonutrition in Liver Resection for Cancer

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Sep 13, 2018

Actual Study Completion Date :

Sep 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Impact control ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery	Dietary Supplement: Oral immunonutrition Powder 74g within 250ml of water, 3 times per day during 7 days before surgery Other Names: ORAL IMPACT
Placebo Comparator: Placebo Placebo	Dietary Supplement: Placebo Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Arm

Intervention/Treatment

Experimental: Impact control

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

Dietary Supplement: Oral immunonutrition

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

Other Names:

ORAL IMPACT

Placebo Comparator: Placebo

Placebo

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

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

Length of hospital stay [30 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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