Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

Hepatectomy Clinical Trial

— PROPILS  

Official title:

Interest of Preoperative Immunonutrition in Liver Resection for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041871
• Other study ID #: P120207
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 13, 2018

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elective Hepatectomy
• Hepatectomy
• Malignant Tumors
• Neoplasms

Intervention

Dietary Supplement:
• Oral immunonutrition
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
• Placebo
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Locations

Country	Name	City	State
France	AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Nestlé Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN		In the first 30 postoperative days after Liver surgery
Secondary	Length of hospital stay		30 days after surgery