UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006297 |
|---|---|
| Receipt number | R000007455 |
| Scientific Title | Multicenter study on the usefulness of EUS-FNA in the diagnosis of autoimmune pancreatitis. |
| Date of disclosure of the study information | 2011/09/06 |
| Last modified on | 2014/06/12 10:15:50 |
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Basic information
Public title
Multicenter study on the usefulness of EUS-FNA in the diagnosis of autoimmune pancreatitis.
Acronym
Multicenter study on diagnostic usefulness of EUS-FNA for AIP.
Scientific Title
Multicenter study on the usefulness of EUS-FNA in the diagnosis of autoimmune pancreatitis.
Scientific Title:Acronym
Multicenter study on diagnostic usefulness of EUS-FNA for AIP.
Region
| Japan |
Condition
Condition
Autoimmune pancreatitis(AIP)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study on the usefulness of EUS-FNA in the diagnosis of AIP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility study of the EUS-FNA in the diagnosis of type 1 AIP.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Cases matching the imaging criterion of "Asian Diagnostic Criteria for Autoimmune Pancreatitis", or "International Consensus Diagnostic Criteria for Autoimmune Pancreatitis" are included.
2.Cases with Performance Status 0-1 are included.
3.Cases without major organ insufficiecy are included.
4.Cases with written and oral informed consent are included.
Key exclusion criteria
1.Cases with steroid therapy within three months before EUS-FNA are excluded.
2.Cases with uncontrolled infections, active tuberculosis etc are excluded.
3.Cases with severe drug allergy are excluded.
4.Cases with difficulty in the performance of endoscopy are excluded.
5.Cases with malignancy are excluded.
6.Cases with severe complications are excluded.
7.Cases with pregnancy, lactating, possibility of pregnancy, or will of pregnancy are excluded.
8.Cases with severe mental disorder are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsuruma-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65, Tsuruma-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 06 | 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
| 2011 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
Multicenter study on diagnostic usefulness of EUS-FNA for AIP.
Exploratory study on the usefulness of EUS-FNA in the diagnosis of AIP.
Feasibility study of the EUS-FNA in the diagnosis of type 1 AIP.
Management information
Registered date
| 2011 | Year | 09 | Month | 06 | Day |
Last modified on
| 2014 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007455
