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

Primary Purpose

Liver Cancer, Cirrhosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Omega-3 Fatty Acid-Based Parenteral Nutrition
Structolipid
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cancer focused on measuring omega-3, Progression, parenteral nutrition

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hepatic Surgery Center of Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Trial group

Arm Description

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

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

Outcomes

Primary Outcome Measures

complications (blood test for liver and renal function, urine output, postoperative complications)
blood test for liver and renal function, urine output, postoperative complications
hospital stay (time of hospital stay after surgery)
the time of hospital stay after surgery

Secondary Outcome Measures

mortality
death within 30 days after surgery

Full Information

First Posted
December 12, 2014
Last Updated
August 20, 2018
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02321202
Brief Title
Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
Official Title
Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Cirrhosis
Keywords
omega-3, Progression, parenteral nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days.
Arm Title
Trial group
Arm Type
Experimental
Arm Description
For postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Omega-3 Fatty Acid-Based Parenteral Nutrition
Other Intervention Name(s)
trial
Intervention Description
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
Intervention Name(s)
Structolipid
Other Intervention Name(s)
control
Intervention Description
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.
Primary Outcome Measure Information:
Title
complications (blood test for liver and renal function, urine output, postoperative complications)
Description
blood test for liver and renal function, urine output, postoperative complications
Time Frame
14 days postoperatively
Title
hospital stay (time of hospital stay after surgery)
Description
the time of hospital stay after surgery
Time Frame
14 days postoperatively
Secondary Outcome Measure Information:
Title
mortality
Description
death within 30 days after surgery
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, M.D.
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Hepatic Surgery Center of Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
1802177
Citation
Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6.
Results Reference
background
PubMed Identifier
17476210
Citation
Carter BA, Shulman RJ. Mechanisms of disease: update on the molecular etiology and fundamentals of parenteral nutrition associated cholestasis. Nat Clin Pract Gastroenterol Hepatol. 2007 May;4(5):277-87. doi: 10.1038/ncpgasthep0796.
Results Reference
background
PubMed Identifier
1727984
Citation
Verdery R. Perioperative total parenteral nutrition in surgical patients. N Engl J Med. 1992 Jan 23;326(4):273; author reply 274. No abstract available.
Results Reference
background
PubMed Identifier
19520466
Citation
Plauth M, Cabre E, Campillo B, Kondrup J, Marchesini G, Schutz T, Shenkin A, Wendon J; ESPEN. ESPEN Guidelines on Parenteral Nutrition: hepatology. Clin Nutr. 2009 Aug;28(4):436-44. doi: 10.1016/j.clnu.2009.04.019. Epub 2009 Jun 11.
Results Reference
background
PubMed Identifier
12553951
Citation
Koller M, Senkal M, Kemen M, Konig W, Zumtobel V, Muhr G. Impact of omega-3 fatty acid enriched TPN on leukotriene synthesis by leukocytes after major surgery. Clin Nutr. 2003 Feb;22(1):59-64. doi: 10.1054/clnu.2002.0592.
Results Reference
background
PubMed Identifier
27614675
Citation
Zhang B, Wei G, Li R, Wang Y, Yu J, Wang R, Xiao H, Wu C, Leng C, Zhang B, Chen XP. n-3 fatty acid-based parenteral nutrition improves postoperative recovery for cirrhotic patients with liver cancer: A randomized controlled clinical trial. Clin Nutr. 2017 Oct;36(5):1239-1244. doi: 10.1016/j.clnu.2016.08.002. Epub 2016 Aug 31.
Results Reference
derived

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

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