UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062435 |
|---|---|
| Receipt number | R000071388 |
| Scientific Title | Evaluation of the clinical utility of a novel EUS-FNB needle for solid pancreatic lesions: a multicenter prospective observational study |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/01 16:13:54 |
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Basic information
Public title
An observational study of endoscopic ultrasound-guided tissue sampling for solid pancreatic lesion
Acronym
CC study
Scientific Title
Evaluation of the clinical utility of a novel EUS-FNB needle for solid pancreatic lesions: a multicenter prospective observational study
Scientific Title:Acronym
CC study
Region
| Japan |
Condition
Condition
solid pancreatic lesion
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively collect and analyze data on tissue acquisition and pathological diagnosis in patients undergoing EUS-FNA with a novel FNB needle as part of routine clinical care for solid pancreatic Lesions.
Basic objectives2
Others
Basic objectives -Others
Evaluation of diagnostic accuracy (the accuracy of the pathological diagnosis obtained by EUS-FNA using the novel FNB needle, assessed against the final diagnosis)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of the histological diagnosis obtained by EUS-FNA using the novel FNB needle, assessed against the final diagnosis (surgical or autopsy pathology; or, when unavailable, the clinical diagnosis established after follow-up to 6 months or death after the procedure).
Key secondary outcomes
Technical success rate, defined as the proportion of patients in whom the two planned needle passes were completed (assessed at the end of the procedure)
Rate of adequate histological sampling, defined as the proportion of patients whose specimens scored 3 or higher on the Gerke scoring system (assessed at pathological evaluation)
Diagnostic accuracy of the cytological diagnosis, assessed against the final diagnosis within 6 months after the procedure
Rate of specimens adequate for comprehensive genomic profiling, defined as the proportion of patients whose specimens contained a tumor cell area of 5 mm2 or greater (assessed at pathological evaluation)
Association between the length of the white core specimen and diagnostic accuracy, including correlation analysis and determination of cut-off values by ROC analysis
Association between the length of the white core specimen and the rate of specimens adequate for comprehensive genomic profiling, including correlation analysis and determination of cut-off values by ROC analysis
Incidence of adverse events within 2 weeks after the procedure (pancreatitis, bleeding, perforation, fever, abdominal pain)
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
Solid pancreatic lesion 10 mm or larger scheduled to undergo EUS-FNA as part of routine clinical care
Age 18 years or older
Written informed consent obtained from the patient
Key exclusion criteria
Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued
Platelet count of 50,000/uL or below, or PT-INR of 1.5 or higher or PT-INR of 1.5 or higher on blood testing within the preceding month
Previous upper gastrointestinal surgery (except Billroth I reconstruction)
Possible pregnancy
Patients in whom the novel FNB needle was not used for any reason
Patients judged inappropriate for the study by the principal or sub-investigators
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Shiga university of medical science
Division name
Department of Gastroenterology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Yamashita |
Organization
Shiga university of medical science
Division name
Department of Gastroenterology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482217
Homepage URL
hqmed2@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medical science
Institute
Department
Personal name
Funding Source
Organization
Shiga university of medical science
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
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | 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 | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study examining the associations between the following factors and outcomes.
Factors examined: length of the white core specimen, tumor size, tumor location, histological subtype (adenocarcinoma, benign lesions, etc.), and patient characteristics.
Outcomes: accuracy of the pathological diagnosis obtained by EUS-FNA compared with the final diagnosis; rate of adequate histological sampling (Gerke score of 3 or higher); and rate of specimens adequate for comprehensive genomic profiling (tumor cell area of 5 mm2 or greater).
These associations are analyzed using correlation analysis and ROC analysis to determine cut-off values, together with univariate and multivariate logistic regression analysis to identify independent associated factors.
The type of puncture needle is determined by the routine clinical practice of each institution and the judgment of the endoscopist, and is not influenced by this study.
Management information
Registered date
| 2026 | Year | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071388
