UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061333 |
|---|---|
| Receipt number | R000070162 |
| Scientific Title | A multicenter prospective observational study evaluating the usefulness of pancreatic duct biopsy for localized pancreatic duct stricture |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 14:19:27 |
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Basic information
Public title
A study to evaluate the usefulness of pancreatic duct biopsy for pancreatic duct narrowing
Acronym
PDB study(Pancreatic Duct Biopsy study)
Scientific Title
A multicenter prospective observational study evaluating the usefulness of pancreatic duct biopsy for localized pancreatic duct stricture
Scientific Title:Acronym
PDB study(Pancreatic Duct Biopsy study)
Region
| Japan |
Condition
Condition
pancreatic duct stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the diagnostic performance and safety of pancreatic duct biopsy for localized pancreatic duct stricture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of pancreatic duct biopsy
Key secondary outcomes
Technical success rate of pancreatic duct biopsy
Sensitivity and specificity of pancreatic duct biopsy
Diagnostic performance of SPACE
Adverse events
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 undergoing ERP for pancreatic duct stricture
Age >=18 years
Written informed consent obtained
Key exclusion criteria
Performance status >=3
Anatomical difficulty for the procedure
Pregnant patients
Patients deemed inappropriate by the investigator
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Endoscopic Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku Okayama
TEL
0862357000
pa793ygx@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku Okayama
TEL
0862357000
Homepage URL
pvaq8exp@s.okayama-u.ac.jp
Sponsor or person
Institute
No funding
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee, Okayama University (Medical Division)
Address
2-5-1 Shikata-cho, Kita-ku Okayama
Tel
0862357000
ouh-crrb@adm.okayama-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
| 2026 | Year | 04 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study. Patients with localized pancreatic duct stricture are enrolled, and pancreatic duct biopsy is performed as part of routine clinical practice, followed by SPACE using ENPD. Diagnostic performance and safety of pancreatic duct biopsy, SPACE, and their combination are evaluated within the same patients.
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070162
