Clinical trial NCT03376945: Application of n-3 Fatty to Patient of Jaundice
Official title: Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Jaundice
Surgical Procedure, Unspecified
Keywords: n-3
Parenteral nutrition
Jaundice
Propensity score match
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.The trail included obstructive jaundice patients ≥20 years who received PN treatment for ≥5 days for maintenance and improvement of their nutrition status round the operation period. All patients received PN along with the three macronutrients, compounded in an "All-In-One" manner, included amino acids, lipids and glucose, electrolytes, and micronutrients (trace elements and vitamins). The administration was performed with a perfusion pump through a central line within 24 h.

Brief summary: The safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for patients with obstructive jaundice.

Detailed description: Lipid emulsion enriched in n-3 fatty acid (FA) has been reported to improve postoperative recovery for surgical patients with biliary tract disease, and to improve laboratory and clinical outcomes. The role of it for postoperative patients with jaundice is not clear yet. The object of this research was to evaluate the safety and efficacy of n-3 fatty acid-based parenteral nutrition (PN) for patients with jaundice following Surgical procedure.

This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.

Eligibility criteria: Inclusion Criteria:

* the diagnosis of obstructive jaundice must be clear (serum toal bilirubin \>51.3umol/L \& Imaging evidence), and the obstruction is located in the extrahepatic bile duct;
* Duration of Jaundice is less than 2 weeks;
* Nutritional support is needed
* Nutritional support was administrated during the perioperative period;
* Drainage treatment is effective.

Exclusion Criteria:

* Contraindication for surgical procedure, including Child-Pugh Classification C, severe hemorrhagic disorders, gastrointestinal hemorrhage, acute infectious disease, active phase of chronic hepatitis B \& C, severe circulatory disease, renal failure pre -operation, and other unknown cause;
* Abandon treatment;
* Length of stay in hospital \<5 day;
* Nutrition support \<5 day;
* Conservative treatment;
* Incomplete data;
* Allergic reactions against PN.

Primary outcomes:
measure: Safety (complications)
timeFrame: postoperative period（1 month ）
measure: velocity of the serum total bilirubin clearance
timeFrame: postoperative period（1 month ）
Secondary outcomes:
measure: kidney function
timeFrame: postoperative period（1 month ）
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, Doctor
role: STUDY_CHAIR
References:
citation: Gong Q, Zhu P, Zhang B, Shu C, Ding Z, Wu J, Zhang B, Chen XP. Safety and efficacy of n-3 fatty acid-based parenteral nutrition in patients with obstructive jaundice: a propensity-matched study. Eur J Clin Nutr. 2018 Aug;72(8):1159-1166. doi: 10.1038/s41430-018-0256-1. Epub 2018 Jul 13.