Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02321202
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoping Chen, 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..

Condition or disease Intervention/treatment Phase
Liver Cancer Cirrhosis Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition Drug: Structolipid Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
Study Start Date : March 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Active Comparator: Control group
For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days.
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.
Other Name: control

Experimental: Trial group
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
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.
Other Name: trial




Primary Outcome Measures :
  1. complications (blood test for liver and renal function, urine output, postoperative complications) [ Time Frame: 14 days postoperatively ]
    blood test for liver and renal function, urine output, postoperative complications

  2. hospital stay (time of hospital stay after surgery) [ Time Frame: 14 days postoperatively ]
    the time of hospital stay after surgery


Secondary Outcome Measures :
  1. mortality [ Time Frame: 30 days postoperatively ]
    death within 30 days after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321202


Locations
Layout table for location information
China, Hubei
Hepatic Surgery Center of Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Layout table for investigator information
Study Chair: Xiaoping Chen, M.D. Huazhong University of Science and Technology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xiaoping Chen, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02321202     History of Changes
Other Study ID Numbers: bhzhang001
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Keywords provided by Xiaoping Chen, Huazhong University of Science and Technology:
omega-3
Progression
parenteral nutrition

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases