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Completed

NCT Number: NCT03376945

Application of n-3 Fatty to Patient of Jaundice

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatic Surgery Center of Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trail cohort

Drug

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.

Other names: trail

control cohort

Drug

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.

Other names: control

Primary outcomes

  1. Safety (complications)

    Time frame: postoperative period(1 month )

    postoperative complications

  2. velocity of the serum total bilirubin clearance

    Time frame: 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 outcomes

  1. kidney function

    Time frame: postoperative period(1 month )

    blood test for GFR and creatinine

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2017
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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