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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018502
Receipt No. R000021411
Scientific Title Study of chronic pancreatitis judging from EUS findings
Date of disclosure of the study information 2015/07/31
Last modified on 2015/07/31

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Basic information
Public title Study of chronic pancreatitis judging from EUS findings
Acronym Study of chronic pancreatitis judging from EUS findings
Scientific Title Study of chronic pancreatitis judging from EUS findings
Scientific Title:Acronym Study of chronic pancreatitis judging from EUS findings
Region
Japan

Condition
Condition chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although the main risk factor for CP is said to be alcohol abuse, such abnormalities can be seen in patients without alcohol abuse actually. It is also said that smoking, aging and gender are involved in the onset and progress of the CP. However, there are few data on the etiology of CP, and the significant influencing factors except alcohol on pancreatic EUS findings and diagnosis is still unclear.
The aim of this retrospective study was to determine clinical background of each EUS findings appearance.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relations with EUS findings of chronic pancreatitis and the patient background
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 The patient that the detailed observation of the pancreas by EUS was accomplished for a disease close inspection from 2010 through 2014 at the Fukushima attendance Tsu General Hospital and the Fukushima Medical College Aizu medical center.
Key exclusion criteria Exclusion criteria were: age less than 20 years, abstinence from alcohol abuse, and past surgical procedures that could impair the complete visualization of the pancreas, pancreatic cancer.
Target sample size 345

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Yamabe
Organization Fukushima Medical University Aizu Medical Center
Division name Gastoroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL 0242-75-2100
Email akaneko@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Yamabe
Organization Fukushima Medical University Aizu Medical Center
Division name Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL 0242-75-2199
Homepage URL
Email akaneko@fmu.ac.jp

Sponsor
Institute Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization organization
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
Address
Tel
Email

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 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 02 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 Without intervention, be the observational studies using samples.
A study period is from February, 2015 to November, 2015.

Management information
Registered date
2015 Year 07 Month 31 Day
Last modified on
2015 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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