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Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study

Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study - Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060215
Enrollment
700
Registered
2026-02-01
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid lesions in the pancreaticobiliary region and adjacent organs detectable by endoscopic ultrasonography (EUS), including the hepatic hilum, duodenum, and lymph nodes

Interventions

None listed

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Detection rate of EUS-AI for solid pancreaticobiliary lesions scheduled for EUS-guided tissue acquisition (EUS-TA)

Countries

Japan

Contacts

Public ContactSho Takahashi

Graduate School of Medicine, Juntendo University Department of Gastroenterology

sho-takahashi@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026