Application of n-3 Fatty to Patient of Jaundice

Completed

• Conditions: Obstructive Jaundice; Surgical Procedure, Unspecified
• Interventions: Drug: trail cohort; Drug: control cohort

• Registration Number: NCT03376945
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-15
• Status Verified: 2017-12
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
trail cohort	trail cohort	n-3 FAs
control cohort	control cohort	Structolipid

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
kidney function	postoperative period（1 month ）	blood test for GFR and creatinine

Trial Locations

Locations (1)

Hepatic Surgery Center of Tongji Hospital; 🇨🇳 Wuhan, Hubei, China