UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060215 |
|---|---|
| Receipt number | R000068874 |
| Scientific Title | Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/12/26 16:45:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study
Acronym
Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study
Scientific Title
Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study
Scientific Title:Acronym
Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study
Region
| Japan |
Condition
Condition
Solid lesions in the pancreaticobiliary region and adjacent organs detectable by endoscopic ultrasonography (EUS), including the hepatic hilum, duodenum, and lymph nodes
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate the detection performance of an AI-assisted endoscopic ultrasonography system (EUS-AI) for solid pancreaticobiliary lesions. Specifically, in patients with solid pancreaticobiliary lesions for whom EUS-guided tissue acquisition (EUS-TA) is planned to establish a definitive diagnosis, we will record and assess whether the AI system detects the target lesion during real-time EUS observation. Based on these data, the tumor detection rate of EUS-AI will be calculated.
In addition, secondary analyses will be performed to investigate the impact of lesion location, lesion size, disease entity, operator experience, and pathological diagnosis on AI-based lesion detection. This study is designed as a pilot investigation to clarify the performance of EUS-AI in detecting solid lesions on EUS images under real-world clinical conditions, with the aim of facilitating future improvements in diagnostic accuracy and potential applications in endoscopist training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of EUS-AI for solid pancreaticobiliary lesions scheduled for EUS-guided tissue acquisition (EUS-TA)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adult patients aged 20 years or older at the time of obtaining informed consent.
2.Patients with suspected solid lesions in the pancreaticobiliary region or adjacent organs detectable by endoscopic ultrasonography (EUS), including the hepatic hilum, duodenum, and lymph nodes, for whom EUS-guided tissue acquisition (EUS-TA) was planned to establish a definitive diagnosis.
This includes cases in which EUS observation was performed regardless of whether EUS-TA was ultimately carried out.
3.Patients in whom EUS observation with concomitant use of EUS-AI can be performed as part of routine clinical practice.
4.Patients who have received a sufficient explanation of the purpose and content of this study and have provided written informed consent of their own free will.
Key exclusion criteria
1.Patients in whom EUS examination is deemed difficult due to poor general condition and inability to undergo sedation.
2.Patients who have previously undergone EUS-AI for the same target lesion and are scheduled to undergo EUS-guided tissue acquisition (EUS-TA) for purposes such as tumor panel testing.
3.Patients who are judged by the principal investigator or sub-investigators to be inappropriate for inclusion in this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
03-3813-3111
sho-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
sho-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo 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
Graduate School of Medicine, Juntendo University
Address
2-1-1 Hongo, Bunkyo-Ku, Tokyo, Japan
Tel
03-3813-3111
sho-takahashi@juntendo.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
順天堂大学医学部附属順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective multicenter observational study. During routine clinical endoscopic ultrasonography (EUS) examinations, observations are performed with the concomitant use of an AI-assisted lesion detection program (EUS-AI). Patients with solid pancreaticobiliary lesions for whom EUS-guided tissue acquisition (EUS-TA) is planned are included, and whether the AI system detects the target lesion during EUS observation is recorded and evaluated. No intervention is performed, and all diagnostic and therapeutic decisions are made at the discretion of the attending physician.
Management information
Registered date
| 2025 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068874
