Application of n-3 Fatty to Patient of Jaundice

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376945
• Other study ID #: Chenxp009
• Status: Completed
• Phase: N/A
• First received: December 5, 2017
• Last updated: December 13, 2017
• Start date: January 1, 2014
• Est. completion date: October 15, 2017

Study information

• Verified date: December 2017
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 15, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice
• Surgical Procedure, Unspecified

Intervention

Drug:
• trail cohort
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.
• control cohort
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 (?-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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (complications)	postoperative complications	postoperative period(1 month )
Primary	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	kidney function	blood test for GFR and creatinine	postoperative period(1 month )