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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024625
Receipt No. R000027677
Scientific Title The difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia
Date of disclosure of the study information 2016/10/30
Last modified on 2022/05/04

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Basic information
Public title The difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia
Acronym The effect of collection of fatty acids in biliary atresia
Scientific Title The difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia
Scientific Title:Acronym The effect of collection of fatty acids in biliary atresia
Region
Japan

Condition
Condition biliary atresia
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the impact of difference of profile of fatty acids and eicosanoids to the prognosis of biliary atresia, and the effect of prognosis by the correction of them.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of the jaundice disappearance and liver transplantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EPADEL 20-40 mg/kg/d
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Biliary atresia
Key exclusion criteria none
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hiroo
Middle name
Last name Uchida
Organization Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name Pediatric Surgery
Zip code 466-8550
Address 65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL 052-744-2959
Email hiro2013@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Sumida
Organization Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name Pediatric Surgery
Zip code 466-8550
Address 65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL 052-744-2959
Homepage URL
Email wsumida@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Certified Review Board
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel 052-744-2479
Email ethics@med.nagoya-u.ac.jp

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 名古屋大学医学部付属病院 (愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 30 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 30
Results Though the number of cases was not large
enough to evaluate a statistically significant difference, the median M2BPGi was 0.96 in 7 cases of EPA group, and the median M2BPGi was 2.29 in 11 patients of the non-EPA group.M2BPGi tended to be lower in the EPA group.
Results date posted
2022 Year 05 Month 04 Day
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 Terminated
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
2019 Year 01 Month 23 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2022 Year 01 Month 17 Day
Date analysis concluded
2022 Year 01 Month 17 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 29 Day
Last modified on
2022 Year 05 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027677

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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