UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024625 |
|---|---|
| Receipt number | 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 09:45:36 |
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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
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
wsumida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
