Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-09-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatectomy Elective Hepatectomy Malignant Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Impact control

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

Group Type EXPERIMENTAL

Oral immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Oral immunonutrition

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ORAL IMPACT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No