UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042732 |
|---|---|
| Receipt number | R000048777 |
| Scientific Title | Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2023/12/14 16:26:47 |
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Basic information
Public title
Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Acronym
Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Scientific Title
Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Scientific Title:Acronym
Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Region
| Japan |
Condition
Condition
pancreaticobiliary maljunction
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of different types of confluence form in pancreaticobiliary maljunction on chronic inflammation and carcinogenesis of the gallbladder epithelium
Basic objectives2
Others
Basic objectives -Others
To be able to infer pathological findings of gallbladder epithelium from the confluence form of pancreaticobiliary maljunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between pancreatic duct and bile duct confluent angle, common bile duct morphology, bile duct diameter at the junction site and pathological findings of gallbladder epithelium
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
| 1 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with pancreaticobiliary maljunctionwho underwent surgery at osaka city university
Key exclusion criteria
Patients with pancreaticobiliary maljunction who were referred to osaka city university after undergoing surgery at another hospital
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Horiike |
Organization
Osaka City University
Division name
pediatric surgery
Zip code
5458585
Address
1-4-3, Asahi-machi,Abeno-ku Osaka
TEL
0666453841
masakihoriike1031@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | Horiike |
| Last name | Horiike |
Organization
Osaka City University
Division name
pediatric surgery
Zip code
5458585
Address
1-4-3, Asahi-machi,Abeno-ku Osaka
TEL
0666453841
Homepage URL
masakihoriike1031@gmail.com
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
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
Osaka City University
Address
1-4-3,Asahi-machi,Abeno-ku Osaka
Tel
0666453841
masakihoriike1031@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 11 | 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
24
Results
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
observational examination
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048777
