Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer

NCT02041871 | Completed

• 1 other identifier: P120207
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatectomy; Elective Hepatectomy; Malignant Tumors

Keywords

Liver Surgery; Hepatectomy; Immunonutrition; Cancer; Morbidity; Postoperative complication

Outcome Measures

Primary Outcomes (1)

• Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN

  In the first 30 postoperative days after Liver surgery

Secondary Outcomes (1)

• Length of hospital stay

  30 days after surgery

Study Arms (2)

Impact control

EXPERIMENTAL

ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Dietary Supplement: Oral immunonutrition

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Oral immunonutrition DIETARY_SUPPLEMENT

Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Also known as: ORAL IMPACT

Impact control

Placebo DIETARY_SUPPLEMENT

Powder 74g within 250ml of water, 3 times per day during 7 days before surgery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Nestlé Foundation: collaborator

Study Sites (1)

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Villejuif, 94800, France

Location

Related Publications (1)

• 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.

  PMID: 25523036 DERIVED

MeSH Terms

Conditions

Neoplasms; Postoperative Complications

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Denis CASTAING, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: September 1, 2013
• Primary Completion: September 13, 2018
• Study Completion: September 13, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-02

Locations

FR (1)