UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045497 |
|---|---|
| Receipt number | R000051640 |
| Scientific Title | Early Chronic Pancreatitis Findings on EUS are Associated with Pancreatic Fibrosis, Chronic Inflammation, and Atrophy |
| Date of disclosure of the study information | 2021/09/16 |
| Last modified on | 2021/11/16 09:04:09 |
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Basic information
Public title
Early Chronic Pancreatitis Findings on EUS are Associated with Pancreatic Fibrosis, Chronic Inflammation, and Atrophy
Acronym
EUS findings of Early CP and Histology
Scientific Title
Early Chronic Pancreatitis Findings on EUS are Associated with Pancreatic Fibrosis, Chronic Inflammation, and Atrophy
Scientific Title:Acronym
EUS findings of Early CP and Histology
Region
| Japan |
Condition
Condition
intraductal papillary mucinous neoplasm, pancreatic neuroendocrine neoplasm, pancreatic ductal carcinoma in body/tail of the pancreas, and distal cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the associations of between EUS findings of early CP and histology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Our primary hypothesis testing evaluated the statistical association between EUS findings (hyperechoic foci/stranding or lobularity) and histology (pancreatic fibrosis, inflammation, or atrophy).
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged over 20 years
2)The clinical data of 221 patients with pancreatic tumor or distal cholangiocarcinoma who underwent preoperative EUS and pancreatic surgery from January 2010 to November 2020 were collected.
Key exclusion criteria
1)Patients who have requested not to participate in this study based on public information.
2) Patients whose pathology specimens do not contain evaluable pancreatic tissue.
3) Patients deemed inappropriate by the principal investigator.
Target sample size
221
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
0783826305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Inomata |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
0783826305
Homepage URL
inomat@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal Medicine
Kobe University Graduate 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
Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
0783826305
rinri@med.kobe-u.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
| 2021 | Year | 09 | Month | 16 | 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
221
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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information included age, sex, BMI, diabetes mellitus, alcohol consumption, and smoking status (never, former, or current).
Early CP EUS indings and histology of background pancreas were also collected.
Management information
Registered date
| 2021 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051640
| 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 |
