UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062290 |
|---|---|
| Receipt number | R000071287 |
| Scientific Title | Multicenter observational study of endoscopic ultrasound-guided tissue acquisition for ampullary tumor |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/21 15:58:41 |
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Basic information
Public title
Multicenter observational study of endoscopic ultrasound-guided tissue acquisition for ampullary tumor
Acronym
Multicenter observational study of endoscopic ultrasound-guided tissue acquisition for ampullary tumor
Scientific Title
Multicenter observational study of endoscopic ultrasound-guided tissue acquisition for ampullary tumor
Scientific Title:Acronym
Multicenter observational study of endoscopic ultrasound-guided tissue acquisition for ampullary tumor
Region
| Japan |
Condition
Condition
Ampullary tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of endoscopic ultrasound-guided tissue acquisition for ampullary tumor
Basic objectives2
Others
Basic objectives -Others
Diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of EUS-TA for ampullary tumors
Key secondary outcomes
1.Sensitivity and specificity
2. Necessity/utility of rapid on-site evaluation (ROSE/MOSE)
3.Factors associated with diagnostic difficulty cases
4.Adverse events
5.Technical success rates
6.Overall survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Over 20 years old
2. Patients with suspected ampullary tumor on imaging modalities
3. Patients with performance status 2 or less
4. Patients requiring EUS-TA for ampullary tumor
Key exclusion criteria
1. Patients deemed ineligible by the principal investigator
2. Patients who did not undergo EUS-TA for ampullary tumor
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Fujimori |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
TEL
+81-92-642-5285
fujimori.nao.239@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Ohno |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
TEL
+81-92-642-5285
Homepage URL
showa2644aki1aki2@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu university center for clinical and translational research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
Tel
+81-92-642-6254
ijkseimei@jimu.kyushu-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 | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter observational study
Management information
Registered date
| 2026 | Year | 07 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071287
