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

Phase 4

Completed

• Conditions: Liver Cancer; Cirrhosis
• Interventions: Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition; Drug: Structolipid

• Registration Number: NCT02321202
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
mortality	30 days postoperatively	death within 30 days after surgery

Trial Locations

Locations (1)

Hepatic Surgery Center of Tongji Hospital; 🇨🇳 Wuhan, Hubei, China