Application of n-3 Fatty to Patient of Jaundice

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study

Conditions
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Obstructive Jaundice, Surgical Procedure, Unspecified

Intervention / Treatment
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* Drug: trail cohort
* Drug: control cohort


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| trail cohort<br>n-3 FAs | Drug: trail cohort<br>* 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.<br>* Other names: trail;|
| control cohort<br>Structolipid | Drug: control cohort<br>* 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.<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (complications) | postoperative complications | postoperative period（1 month ） | 
| velocity of the serum total bilirubin clearance | the velocity of the serum TBIL clearance, which was calculated according to formula behind: (formal TB -TB of current) /time interval | postoperative period（1 month ） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function | blood test for GFR and creatinine | postoperative period（1 month ） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3, Jaundice, Parenteral nutrition, Propensity score match