title: Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrial.gov: NCT02041871.
authors.affiliation: Centre Hépato-biliaire, Paul Brousse Hospital - APHP, 12-14 Avenue Paul Vaillant Couturier, 94800 Villejuif, France. oriana.ciacio@pbr.aphp.fr.
authors.forename: Oriana
authors.initials: O
authors.lastname: Ciacio
authors.forename: Thibault
authors.initials: T
authors.lastname: Voron
authors.forename: Gabriella
authors.initials: G
authors.lastname: Pittau
authors.forename: Maité
authors.initials: M
authors.lastname: Lewin
authors.forename: Eric
authors.initials: E
authors.lastname: Vibert
authors.forename: René
authors.initials: R
authors.lastname: Adam
authors.forename: Antonio
authors.initials: A
authors.lastname: Sa Cunha
authors.forename: Daniel
authors.initials: D
authors.lastname: Cherqui
authors.forename: Astrid
authors.initials: A
authors.lastname: Schielke
authors.forename: Olivier
authors.initials: O
authors.lastname: Soubrane
authors.forename: Olivier
authors.initials: O
authors.lastname: Scatton
authors.forename: Chady
authors.initials: C
authors.lastname: Salloum
authors.forename: Daniel
authors.initials: D
authors.lastname: Azoulay
authors.forename: Stéphane
authors.initials: S
authors.lastname: Benoist
authors.forename: Perrine
authors.initials: P
authors.lastname: Goyer
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Vaillant
authors.forename: Laurent
authors.initials: L
authors.lastname: Hannoun
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Boleslawski
authors.forename: Hélène
authors.initials: H
authors.lastname: Agostini
authors.forename: Didier
authors.initials: D
authors.lastname: Samuel
authors.forename: Denis
authors.initials: D
authors.lastname: Castaing
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D019587:Dietary Supplements / Q000191:economics; D004311:Double-Blind Method; D004435:Eating; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods*; D006498:Hepatectomy / Q000009:adverse effects*; D006801:Humans; D007121:Immunocompetence; D057194:Intention to Treat Analysis; D007902:Length of Stay; D008113:Liver Neoplasms / Q000601:surgery*; D008115:Liver Regeneration; D009752:Nutritional Status; D010349:Patient Compliance; D011300:Preoperative Care / Q000191:economics; D011446:Prospective Studies; D012107:Research Design; D055948:Sarcopenia / Q000276:immunology; D013530:Surgical Wound Infection / Q000276:immunology* / Q000517:prevention & control
chemical_list: D000900:Anti-Bacterial Agents