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Published in: BMC Cancer 1/2014

Open Access 01-12-2014 | Study protocol

Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial

Authors: Oriana Ciacio, Thibault Voron, Gabriella Pittau, Maité Lewin, Eric Vibert, René Adam, Antonio Sa Cunha, Daniel Cherqui, Astrid Schielke, Olivier Soubrane, Olivier Scatton, Chady Salloum, Daniel Azoulay, Stéphane Benoist, Perrine Goyer, Jean-Christophe Vaillant, Laurent Hannoun, Emmanuel Boleslawski, Hélène Agostini, Didier Samuel, Denis Castaing

Published in: BMC Cancer | Issue 1/2014

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Abstract

Background

Malnutrition is an independent risk factor of postoperative morbidity and mortality and it’s observed in 20 to 50% of surgical patients. Preoperative interventions to optimize the nutritional status, reduce postoperative complications and enteral nutrition has proven to be superior to the parenteral one. Moreover, regardless of the nutritional status of the patient, surgery impairs the immunological response, thus increasing the risk of postoperative sepsis. Immunonutrition has been developed to improve the immunometabolic host response in perioperative period and it has been proven to reduce significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. We hypothesize that a preoperative oral immunonutrition (ORAL IMPACT®) can reduce postoperative morbidity in liver resection for cancer.

Methods/design

Prospective multicenter randomized placebo-controlled double-blind phase IV trial with two parallel treatment groups receiving either study product (ORAL IMPACT®) or control supplement (isocaloric isonitrogenous supplement - IMPACT CONTROL®) for 7 days before liver resection for cancer. A total of 400 patients will be enrolled. Patients will be stratified according to the type of hepatectomy, the presence of chronic liver disease and the investigator center. The main end-point is to evaluate in intention-to-treat analysis the overall 30-day morbidity. Secondary end-points are to assess the 30-day infectious and non-infectious morbidity, length of antibiotic treatment and hospital stay, modifications on total food intake, compliance to treatment, side-effects of immunonutrition, impact on liver regeneration and sarcopenia, and to perform a medico-economic analysis.

Discussion

The overall morbidity rate after liver resection is 22% to 42%. Infectious post-operative complications (12% to 23%) increase the length of hospital stay and costs and are responsible for a quarter of 30-day mortality. Various methods have been advocated to decrease the rate of postoperative complications but there is no evidence to support or refute the use of any treatment and further trials are required. The effects of preoperative oral immunonutrition in non-cirrhotic patients undergoing liver resection for cancer are unknown. The present trial is designed to evaluate whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for cancer.

Trial registration

Clinicaltrial.gov: NCT02041871.
Appendix
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Metadata
Title
Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial
Authors
Oriana Ciacio
Thibault Voron
Gabriella Pittau
Maité Lewin
Eric Vibert
René Adam
Antonio Sa Cunha
Daniel Cherqui
Astrid Schielke
Olivier Soubrane
Olivier Scatton
Chady Salloum
Daniel Azoulay
Stéphane Benoist
Perrine Goyer
Jean-Christophe Vaillant
Laurent Hannoun
Emmanuel Boleslawski
Hélène Agostini
Didier Samuel
Denis Castaing
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2014
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-14-980

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