Obstructive JaundiceNCT03376945
Application of n-3 Fatty to Patient of Jaundice
An observational study of Obstructive Jaundice and Surgical Procedure, Unspecified, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Jaundice, Surgical Procedure, Unspecified
- What is being tested?
- trail cohort
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 15 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.The trail included obstructive jaundice patients ≥20 years who received PN treatment for ≥5 days for maintenance and improvement of their nutrition status round the operation period. All patients received PN along with the three macronutrients, compounded in an "All-In-One" manner, included amino acids, lipids and glucose, electrolytes, and micronutrients (trace elements and vitamins). The administration was performed with a perfusion pump through a central line within 24 h.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study
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.
Read the 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.
- Being tested
- trail cohort, control cohort
- Keywords
- n-3, Parenteral nutrition, Jaundice, Propensity score match
- Medical subject headings
- Jaundice, Obstructive, Hyperphagia, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trail cohortDrug
Also called trail
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 cohortDrug
Also called control
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.
| Study group | Role | What they receive |
|---|---|---|
| trail cohort | n-3 FAs Receives: Drug: trail cohort | |
| control cohort | Structolipid Receives: Drug: control cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (complications)
postoperative complications
Measured: postoperative period（1 month ）
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
Measured: postoperative period（1 month ）
Secondary outcomes (1)
kidney function
blood test for GFR and creatinine
Measured: postoperative period（1 month ）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2014
- Primary completion1 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Xiaoping Chen, Doctor, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376945
- Sponsor's protocol ID
- Chenxp009
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30006616
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study
- ClinicalTrials.gov ID
- NCT03376945
- Acronym / sponsor ID
- Chenxp009
- Keywords
- n-3, Parenteral nutrition, Jaundice, Propensity score match
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trail cohort | – | Drug: trail cohortn-3 FAs |
| control cohort | – | Drug: control cohortStructolipid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.The trail included obstructive jaundice patients ≥20 years who received PN treatment for ≥5 days for maintenance and improvement of their nutrition status round the operation period. All patients received PN along with the three macronutrients, compounded in an "All-In-One" manner, included amino acids, lipids and glucose, electrolytes, and micronutrients (trace elements and vitamins). The administration was performed with a perfusion pump through a central line within 24 h.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trail cohortAlso: trailDrug: 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 | trail cohort |
| control cohortAlso: controlDrug: 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. | Drug | control cohort |
Primary outcome
Safety (complications)
Time frame: postoperative period（1 month ）
postoperative complications
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
1 secondary outcome
kidney function
Time frame: postoperative period（1 month ）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 30006616Gong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Chen, Doctor study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Jaundice and Surgical Procedure, Unspecified, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (complications) (time frame: postoperative period（1 month ）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.