UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042998 |
|---|---|
| Receipt number | R000049038 |
| Scientific Title | A Comparative study between the diagnostic ability of EUS-FNA with 22-gauge franseen needle and that with 19-gauge franseen needle for autoimmune pancreatitis |
| Date of disclosure of the study information | 2021/01/13 |
| Last modified on | 2023/01/15 18:48:47 |
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Basic information
Public title
A Comparative study between the diagnostic ability of EUS-FNA with 22-gauge franseen needle and that with 19-gauge franseen needle for autoimmune pancreatitis
Acronym
AIP-acquire 19G vs 22G study
Scientific Title
A Comparative study between the diagnostic ability of EUS-FNA with 22-gauge franseen needle and that with 19-gauge franseen needle for autoimmune pancreatitis
Scientific Title:Acronym
AIP-acquire 19G vs 22G study
Region
| Japan |
Condition
Condition
autoimmune pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic ability of EUS-FNA using 19-gauge franseen needle to that with 22-gauge franseen needle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological diagnostic rate of autoimmune pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
A 19-gauge franseen needle is used in EUS-FNA prior to a 22-gauge franseen needle
Interventions/Control_2
A 22-gauge franseen needle is used in EUS-FNA prior to a 19-gauge franseen needle
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
Need for pathological confirmation of type 1 autoimmune pancreatitis
Key exclusion criteria
Coagulopathy
Severe comorbidity(ASA class3 or more)
Low performance status(PS 4)
Severe hemodynamic disease or respiratory disease
Pregnancy or breast-feeding
Not suitable for the study
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Kin |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
0068555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-8111
kin_toshifumi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Kin |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
0068555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-8111
Homepage URL
kin_toshifumi@yahoo.co.jp
Sponsor or person
Institute
Teine-Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Teine-Keijinkai Hospital
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel
011-681-8111
kin_toshifumi@yahoo.co.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
| 2021 | Year | 01 | Month | 13 | 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
57
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049038
| 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 |
