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

Huazhong University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Cirrhosis; Liver Cancer

Treatments: Drug: Structolipid; Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02321202

bhzhang001

Details and patient eligibility

About

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..

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

Control group

Active Comparator group

Description:

For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days.

Treatment:

Drug: Structolipid

Trial group

Experimental group

Description:

For postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days.

Treatment:

Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition