UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057987 |
|---|---|
| Receipt number | R000066291 |
| Scientific Title | A retrospective study of EUS-TA with rapid on-site evaluation to minimize the number of punctures in resectable pancreatic body and tail cancer |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2026/02/02 22:05:46 |
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Basic information
Public title
A retrospective study of EUS-TA for resectable pancreatic body and tail cancer
Acronym
A retrospective study of EUS-TA for resectable pancreatic body and tail cancer
Scientific Title
A retrospective study of EUS-TA with rapid on-site evaluation to minimize the number of punctures in resectable pancreatic body and tail cancer
Scientific Title:Acronym
A retrospective study of EUS-TA with rapid on-site evaluation to minimize the number of punctures in resectable pancreatic body and tail cancer
Region
| Japan |
Condition
Condition
Resectable pancreatic body and tail cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of EUS-TA for resectable pancreatic body and tail cancer by using rapid on-site evaluation to minimize the number of punctures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success rate of EUS-TA, accuracy rate of EUS-TA, concordance rate between ROSE and final cytological diagnoses
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
Patients who underwent EUS-TA for resectable pancreatic body and tail cancer with planned surgical resection at the time of EUS-TA, and a final pathological diagnosis of invasive pancreatic ductal adenocarcinoma.
Key exclusion criteria
1) Patients in whom EUS-TA was performed without clearly visualizing the pancreatic mass
2) Patients in whom invasive pancreatic ductal carcinoma was not suspected at the time of EUS-TA
3) Patients in whom EUS-TA was performed on metastatic lymph nodes
4) Patients with unavailable or undocumented EUS-TA findings or pathological diagnosis details
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
murabayashitoji@m2.gmobb.jp
Public contact
Name of contact person
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
Homepage URL
murabayashitoji@m2.gmobb.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
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
Research Ethics Committee of Ise Red Cross Hospital
Address
1-471-2, Funae, Ise, Mie
Tel
0596-28-2171
jimubu@ise.jrc.or.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 | 05 | Month | 27 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective study
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066291
