Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer

Conditions
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Liver Cancer, Cirrhosis

Intervention / Treatment
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* Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition
* Drug: Structolipid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days. | Drug: Structolipid<br>* 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.<br>* Other names: control;|
| Experimental: Trial group<br>For postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days. | Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition<br>* 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.<br>* Other names: trial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications (blood test for liver and renal function, urine output, postoperative complications) | blood test for liver and renal function, urine output, postoperative complications | 14 days postoperatively | 
| hospital stay (time of hospital stay after surgery) | the time of hospital stay after surgery | 14 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death within 30 days after surgery | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3, Progression, parenteral nutrition