UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047868 |
|---|---|
| Receipt number | R000054225 |
| Scientific Title | Study on relationship and mechanism between pancreatitis-related gene SNPs and post-ERCP pancreatitis development |
| Date of disclosure of the study information | 2022/05/26 |
| Last modified on | 2023/05/27 11:42:16 |
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Basic information
Public title
Study on relationship and mechanism between pancreatitis-related gene SNPs and post-ERCP pancreatitis development
Acronym
Study on post-ERCP pancreatitis-related gene SNPs
Scientific Title
Study on relationship and mechanism between pancreatitis-related gene SNPs and post-ERCP pancreatitis development
Scientific Title:Acronym
Study on post-ERCP pancreatitis-related gene SNPs
Region
| Japan |
Condition
Condition
Pancreaticobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship between the status of pancreatitis-related genes and post-ERCP pancreatitis developmen
Basic objectives2
Others
Basic objectives -Others
To clarify molecular mechanism of post-ERCP pancreatitis development by analysis of IL-6 pathway
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the status of pancreatitis-related genes and post-ERCP pancreatitis (PEP) development: occurrence frequency and severity of PEP, PEP-related laboratory data based on each single nucleotide polymorphism
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients requiring ERCP for examination or treatment
(2)Patients with informed consent for this study
Key exclusion criteria
(1)Patients who have undergone ERCP in the past
(2)Patients without informed consent for this study
(3)Patients deemed inappropriate for this study by the investigator
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
0608648
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 26 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054225
