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

BMC Cancer

Denis Castaing⁴  Didier Samuel⁴  Hélène Agostini⁵  Emmanuel Boleslawski⁶  Laurent Hannoun²  Jean-Christophe Vaillant²  Perrine Goyer²  Stéphane Benoist¹  Daniel Azoulay⁷  Chady Salloum⁷  Olivier Scatton³  Olivier Soubrane³  Astrid Schielke³  Daniel Cherqui⁴  Antonio Sa Cunha⁴  René Adam⁸  Eric Vibert⁴  Maité Lewin⁹  Gabriella Pittau^1,10  Thibault Voron^1,10  Oriana Ciacio⁴ 

[1]Department of Digestive Surgery, Kremlin-Bicêtre Hospital - APHP, 78 rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France

[2]Department of Digestive and Hepato-Pancreato-Biliary Surgery, Pitié-Salpetrière Hospital - APHP, 47-83 Boulevard de l’Hôpital, Paris 75013,France

[3]Department of Hepato-biliairy Surgery and Liver Transplantation, Saint Antoine Hospital - APHP, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, France

[4]UMR-S785 Inserm, Villejuif, France

[5]Clinical Research Unit Paris Sud, Bicêtre Hospital - APHP, 78 Rue du Général Leclerc, Le Kremlin Bicêtre 94275, France

[6]Department of Digestive Surgery and Transplantation, University Hospital of Lille, 2 Avenue Oscar Lambret, 59000 Lille, France

[7]Department of Digestive Surgery, Mondor Hospital - APHP, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France

[8]UMR-S776 Inserm, Villejuif, France

[9]Department of Radiology, Paul Brousse Hospital – APHP, 12-14 Avenue Paul Vaillant Couturier, 94800 Villejuif, France

[10]Centre Hépato-biliaire, Paul Brousse Hospital - APHP, 12-14 Avenue Paul Vaillant Couturier, 94800 Villejuif, France

关键词: Cholangiocarcinoma;    HCC;    Liver metastases;    Immunonutrition;    Hepatectomy;    Liver resection;   

Others  :  1117845
DOI  :  10.1186/1471-2407-14-980

 received in 2014-07-24, accepted in 2014-11-26,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Ciacio et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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