Cirrhosis, Liver Cancer
Conditions
Keywords
omega-3, Progression, parenteral nutrition
Brief summary
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..
Detailed description
A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid hyperinflammatory situations in patients followed major surgery. However, the role of ω-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy. A prospective randomized controlled clinical trial was conducted for cirrhotic patients with liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were applied to the trial group, while only Structolipid to the control group for 5 consecutive days postoperatively.
Interventions
DRUGOmega-3 Fatty Acid-Based Parenteral Nutrition
Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid \[FA\] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
DRUGStructolipid
Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.
Exclusion criteria
* Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)\>30%(12), serum hepatitis B virus (HBV)-DNA\>126 copies/ml and serum alanine aminotransferase (ALT) \> 2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause * Pregnancy * Age of\<18y or\>75y * Performed intraoperative ablation * Unresectable tumor during operation * Allergic reactions against fish or egg proteins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complications (blood test for liver and renal function, urine output, postoperative complications) | 14 days postoperatively | blood test for liver and renal function, urine output, postoperative complications |
| hospital stay (time of hospital stay after surgery) | 14 days postoperatively | the time of hospital stay after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 30 days postoperatively | death within 30 days after surgery |
Countries
China
Outcome results
None listed