UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018502 |
|---|---|
| Receipt number | 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 12:24:35 |
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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
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
akaneko@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021411
