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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321202
• Other study ID #: bhzhang001
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: November 2013

Study information

• Verified date: August 2018
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cancer
• Liver Neoplasms

Intervention

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 (?-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (?-6 FA mainly) to the control group for 5 consecutive days postoperatively.
• 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 (?-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (?-6 FA mainly) to the control group for 5 consecutive days postoperatively.

Locations

Country	Name	City	State
China	Hepatic Surgery Center of Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. Review. — View Citation

Köller M, Senkal M, Kemen M, König 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. — View Citation

Plauth M, Cabré E, Campillo B, Kondrup J, Marchesini G, Schütz 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. — View Citation

Verdery R. Perioperative total parenteral nutrition in surgical patients. N Engl J Med. 1992 Jan 23;326(4):273; author reply 274. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications (blood test for liver and renal function, urine output, postoperative complications)	blood test for liver and renal function, urine output, postoperative complications	14 days postoperatively
Primary	hospital stay (time of hospital stay after surgery)	the time of hospital stay after surgery	14 days postoperatively
Secondary	mortality	death within 30 days after surgery	30 days postoperatively