Clinical trial NCT02041871: Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer
Official title: Interest of Preoperative Immunonutrition in Liver Resection for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatectomy
Elective Hepatectomy
Malignant Tumors
Keywords: Liver Surgery
Hepatectomy
Immunonutrition
Cancer
Morbidity
Postoperative complication
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2014-01-22
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
timeFrame: In the first 30 postoperative days after Liver surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Villejuif
country: France
facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Denis CASTAING, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.