UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058397 |
|---|---|
| Receipt number | R000066510 |
| Scientific Title | Utility of EUS shear wave elastography for diagnosis in pancreatic fibrosis using surgical specimens. |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/08 11:28:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Utility of EUS shear wave elastography for diagnosis in pancreatic fibrosis using surgical specimens.
Acronym
EUS-SWE for pancreatic fibrosis
Scientific Title
Utility of EUS shear wave elastography for diagnosis in pancreatic fibrosis using surgical specimens.
Scientific Title:Acronym
EUS-SWE for pancreatic fibrosis
Region
| Japan |
Condition
Condition
chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to demonstrate the utility of EUS-SWE for quantitative diagnosis of pancreatic fibrosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between EUS-SWE and the degree of pancreatic fibrosis
Key secondary outcomes
The association between EUS findings and the degree of pancreatic fibrosis
The diagnostic ability of EUS-SWE for pancreatic fibrosis
The association between EUS-SWE and postoperative pancreatic fistula
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
Patients who underwent EUS-SWE prior to pancreatectomy
Key exclusion criteria
Patients who could not undergo EUS
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kitano |
| Middle name | |
| Last name | Masayuki |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nakahata |
| Middle name | |
| Last name | Akiya |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
Homepage URL
nakaaki@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, Wakayama
Tel
073-447-2300/ (+81)-73-4472300
waidai@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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients who underwent EUS-SWE in pancreatic parenchyma before pancreatectomy in our hospital between October 2019 and October 2024 were included in this study.
Management information
Registered date
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066510
