UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038735 |
|---|---|
| Receipt number | R000044081 |
| Scientific Title | Elastography with Endoscopic Ultrasonography Shear Wave Measurement for Diagnosing Chronic Pancreatitis |
| Date of disclosure of the study information | 2022/04/03 |
| Last modified on | 2023/12/01 09:23:09 |
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Basic information
Public title
Elastography with Endoscopic Ultrasonography Shear Wave Measurement for Diagnosing Chronic Pancreatitis
Acronym
Chronic pancreatitis with SW-EUS
Scientific Title
Elastography with Endoscopic Ultrasonography Shear Wave Measurement for Diagnosing Chronic Pancreatitis
Scientific Title:Acronym
Chronic pancreatitis with SW-EUS
Region
| Japan |
Condition
Condition
Chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urility of EUS-SWM for CP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation between EUS-SWM and chronic pancreatitis diagnosis or exocrine dysfunction.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
EUS and EUS-SW were performed on the samefor suspicious of chronic pancreatitis
Key exclusion criteria
previous pancreatic surgical procedure and/or total gastrectomy
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Japan
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasunobu |
| Middle name | |
| Last name | Yamashita |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Japan
TEL
073-447-2300
Homepage URL
yasunobu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama City, Japan
Tel
073-447-2300
yasunobu@wakayama-med.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
| 2022 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32511808/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32511808/
Number of participants that the trial has enrolled
40
Results
The EUS-SWM value was positively correlated with the Japan Pancreatic Society criteria stages. The cut-off values of 1.96, 1.96, and 2.34 for diagnosing CP, exocrine dysfunction, and endocrine dysfunctions had 83%, 90%, and 75% sensitivity, respectively, and 100%, 65%, and 64% specificity, respectively.
Results date posted
| 2023 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent EUS, EUS-SWM, and BT-PABA.
Participant flow
Patients of CP or patients who were clinically suspected as CP with abdominal pain and/or history of recurrent pancreatitis were underwent BT-PABA and EUS-SWM
Adverse events
None
Outcome measures
This study is to evaluate the usefulness of EUS-SWM for CP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between January 2019 and March 2022, consecutive patients who undergo EUS and EUS-SW are prospective enrolled in this study.
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044081
| 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 |
