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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016958
Receipt No. R000019683
Scientific Title The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis
Date of disclosure of the study information 2015/03/28
Last modified on 2015/03/28

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Basic information
Public title The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis
Acronym STG and MCT/LCT on acute necroizing pancreatitis
Scientific Title The effect of structured triglyceride and physical mixed MCT/LCT on lipometabolism liver and renal function of patients with acute necroizing pancreatitis
Scientific Title:Acronym STG and MCT/LCT on acute necroizing pancreatitis
Region
Asia(except Japan)

Condition
Condition Completed
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the influnence of STG onlipomeabolism, liver and renal fnction in patients with acute necrotizing pancreatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes STG has a better effect on lipometabolism than physical mixed MCT/LCT in patients with acute necrotizing pancreatitis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Diagnosis as ANP
2)Rquired parenteral nutrition support treatment more than 5 days
Key exclusion criteria Patients with abnormal lipid metabolism
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chen JY
Organization Chinese PLA General Hospital
Division name Hospital and Institute of Hepatobiliary Surgery
Zip code
Address No.28 fuxing road , Beijing, China
TEL +86-010-66938331
Email chensir338@126.com

Public contact
Name of contact person
1st name
Middle name
Last name Chen JY
Organization Chinese PLA General Hospital
Division name Hospital and Institute of Hepatobiliary Surgery
Zip code
Address No.28 fuxing road , Beijing, China
TEL +86-010-66938331
Homepage URL
Email chensir338@126.com

Sponsor
Institute The Human Ethics Committee of the Chinese PLA General Hospital
Institute
Department

Funding Source
Organization Chinese PLA General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Chinese PLA General Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were no harmful to liver and renal function in STG and MCT/LCT ,and STG has a better effect on lipomeabolism than MCT/LCT in patients with ANP
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The liver fnction, renal function and lipometabolism were compared between STG group and MCT/LCT group

Management information
Registered date
2015 Year 03 Month 28 Day
Last modified on
2015 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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