Application of n-3 Fatty to Patient of Jaundice

NCT ID: NCT03376945

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2017-10-15

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.

Conditions

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Obstructive Jaundice Surgical Procedure, Unspecified

Keywords

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n-3 Parenteral nutrition Jaundice Propensity score match

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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trail cohort

n-3 FAs

trail cohort

Intervention Type 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.

control cohort

Structolipid

control cohort

Intervention Type 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.

Interventions

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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 (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.

Intervention Type DRUG

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 (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.

Intervention Type DRUG

Other Intervention Names

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trail control

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xiaoping Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoping Chen, Doctor

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Hepatic Surgery Center of Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Gong Q, Zhu P, Zhang B, Shu C, Ding Z, Wu J, Zhang B, Chen XP. Safety and efficacy of n-3 fatty acid-based parenteral nutrition in patients with obstructive jaundice: a propensity-matched study. Eur J Clin Nutr. 2018 Aug;72(8):1159-1166. doi: 10.1038/s41430-018-0256-1. Epub 2018 Jul 13.

Reference Type DERIVED
PMID: 30006616 (View on PubMed)

Other Identifiers

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Chenxp009

Identifier Type: -

Identifier Source: org_study_id