UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059025 |
|---|---|
| Receipt number | R000067505 |
| Scientific Title | Questionnaire Survey on Endoscopic Treatment for Walled-off Pancreatic Necrosis in Japan |
| Date of disclosure of the study information | 2025/09/07 |
| Last modified on | 2025/09/07 21:47:16 |
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Basic information
Public title
Questionnaire Survey on Endoscopic Treatment for Walled-off Pancreatic Necrosis in Japan
Acronym
Questionnaire Survey on Endoscopic Treatment for Walled-off Pancreatic Necrosis in Japan
Scientific Title
Questionnaire Survey on Endoscopic Treatment for Walled-off Pancreatic Necrosis in Japan
Scientific Title:Acronym
Questionnaire Survey on Endoscopic Treatment for Walled-off Pancreatic Necrosis in Japan
Region
| Japan |
Condition
Condition
Walled-off necrosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey current institutional practices for the management of pancreatic fluid collections (PFCs), identify existing challenges, and clarify priorities for future investigation and clinical practice.
Basic objectives2
Others
Basic objectives -Others
A cross-sectional survey of treatment practices in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of centers that perform EUS-guided drainage within 4 weeks of disease onset provided that sufficient encapsulation is confirmed on cross-sectional imaging.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical institutions in Japan (university hospitals or community/tertiary centers) that provide care for pancreatic fluid collections (PFCs: pseudocysts and/or walled-off necrosis) and perform or participate in decision-making regarding endoscopic management including EUS-guided drainage
One institution-level response provided by a responsible endoscopist (pancreatobiliary specialist)
Ability to complete the online questionnaire and provision of informed consent to participate
Submission within the survey period with no missing data in the primary outcome item
Key exclusion criteria
Institutions that neither perform endoscopic management for PFCs nor participate in decision-making for such management
Individual-level responses or duplicate submissions from the same institution (only the latest/most complete response will be analyzed)
Responses with major missing data in key items or with obvious logical inconsistencies
Submissions outside the survey window or without consent
Institutions outside Japan
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama
Division name
Third department of internal medicine
Zip code
9300152
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7301
yasudaic@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Hayashi |
Organization
Univerisity of Toyama
Division name
Third department of internal medicine
Zip code
9300152
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7301
Homepage URL
hayashi@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
University of Toyama Clinical and Epidemiological Research Ethics Committee
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
Tel
076-434-8866
kenrinri@adm.u-toyama.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
| 2025 | Year | 09 | Month | 07 | 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
73
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
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter cross-sectional questionnaire (observational); unit of observation: institution. Variables include PFC management and indications/procedures of EUS-guided drainage; primary outcome: proportion of centers performing EUS-guided drainage within 4 weeks when sufficient encapsulation is confirmed; no patient-level data collected.
Management information
Registered date
| 2025 | Year | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067505
