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

October 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Interest of Preoperative Immunonutrition in Liver Resection for Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

399

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
Time Frame: In the first 30 postoperative days after Liver surgery
In the first 30 postoperative days after Liver surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Nestlé Foundation

Investigators

  • Principal Investigator: Denis CASTAING, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 13, 2018

Study Completion (Actual)

September 13, 2018

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120207

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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