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Application of n-3 Fatty to Patient of Jaundice

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03376945
Enrollment
106
Registered
2017-12-19
Start date
2014-01-01
Completion date
2017-10-15
Last updated
2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Jaundice, Surgical Procedure, Unspecified

Keywords

n-3, Parenteral nutrition, Jaundice, Propensity score match

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.

Interventions

DRUGtrail 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 (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.

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.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety (complications)postoperative period(1 month )postoperative complications
velocity of the serum total bilirubin clearancepostoperative 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

MeasureTime frameDescription
kidney functionpostoperative period(1 month )blood test for GFR and creatinine

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026