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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-11-30

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..

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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.

Conditions

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Liver Cancer Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Structolipid

Intervention Type DRUG

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.

Trial group

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

Group Type EXPERIMENTAL

Omega-3 Fatty Acid-Based Parenteral Nutrition

Intervention Type DRUG

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.

Interventions

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Omega-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.

Intervention Type DRUG

Structolipid

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.

Intervention Type DRUG

Other Intervention Names

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trial control

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No