UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019768 |
|---|---|
| Receipt number | R000022827 |
| Scientific Title | The efficacy of EUS-FNA with wet suction technique (WEST) for auto immune pancreatitis |
| Date of disclosure of the study information | 2015/11/12 |
| Last modified on | 2022/05/19 09:28:02 |
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Basic information
Public title
The efficacy of EUS-FNA with wet suction technique (WEST) for auto immune pancreatitis
Acronym
The efficacy of EUS-FNA with WEST for AIP
Scientific Title
The efficacy of EUS-FNA with wet suction technique (WEST) for auto immune pancreatitis
Scientific Title:Acronym
The efficacy of EUS-FNA with WEST for AIP
Region
| Japan |
Condition
Condition
Autoimmune pancreatitis (AIP) type 1
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of EUS-FNA with wet suqtion technique (WEST) for AIP type 1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnosability of 4 items described for LPSP in Internal consensus diagnostic criteria
Key secondary outcomes
1.The number of IgG4 positive plasma cells in a high power field
2.Complications
3.The number of needle passes for sampling
4.The number needle passes
5.Whether can take sufficient quantitiy for immunostaining or not
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Needles of EUS-FNA were flushed with saline solution.
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
AIP patients older than 20 years with elevated serum IgG4
Key exclusion criteria
1. AIP patients without elevated serum IgG4.
2. AIP patients who have already been performed steroid therapy.
3. EUS-FNA is impossible (cannot insert the scope, profound bleeding risk, etc)
4. Patients who cannot stop antithorombotic drugs for EUS-FNA.
5. Patients who don't agree with informed consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1202
h-ohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1202
Homepage URL
kita335@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology, Fukushima Medical University, School of Medicine
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
Fukushima Medical University
Address
Hikarigaoka 1, Fukushima City, Japan
Tel
024-547-1825
rs@fmu.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
| 2015 | Year | 11 | Month | 12 | 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
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 01 | 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
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022827
| 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 |
