Hepatectomy Clinical Trial
— PROPILSOfficial title:
Interest of Preoperative Immunonutrition in Liver Resection for Cancer
Verified date | February 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.
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 |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Nestlé Foundation |
France,
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 |
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