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Completed

NCT Number: NCT02041871

Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

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

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Key information

Conditions

Hepatectomy Elective Hepatectomy Malignant Tumors Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Villejuif, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral immunonutrition

Dietary Supplement

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

Other names: ORAL IMPACT

Placebo

Dietary Supplement

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

Primary outcomes

  1. Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN

    Time frame: In the first 30 postoperative days after Liver surgery

Secondary outcomes

  1. Length of hospital stay

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Nestlé Foundation

Registry information

Official study title

Interest of Preoperative Immunonutrition in Liver Resection for Cancer

Acronym: PROPILS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2014
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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