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

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ClinicalTrials.gov Identifier: NCT02041871
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

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 Name: ORAL IMPACT

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery




Primary Outcome Measures :
  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 Outcome Measures :
  1. Length of hospital stay [ Time Frame: 30 days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041871


Locations
France
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Nestlé Foundation
Investigators
Principal Investigator: Denis CASTAING, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02041871     History of Changes
Other Study ID Numbers: P120207
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: February 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver Surgery
Hepatectomy
Immunonutrition
Cancer
Morbidity
Postoperative complication

Additional relevant MeSH terms:
Neoplasms