Clinical trial NCT02321202: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cancer
Cirrhosis
Keywords: omega-3
Progression
parenteral nutrition
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: complications (blood test for liver and renal function, urine output, postoperative complications)
timeFrame: 14 days postoperatively
measure: hospital stay (time of hospital stay after surgery)
timeFrame: 14 days postoperatively
Secondary outcomes:
measure: mortality
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hepatic Surgery Center of Tongji Hospital
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiaoping Chen, M.D.
role: STUDY_CHAIR
References:
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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.
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.
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.
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.
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.