Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060215) titled 'Evaluation of the Usefulness of an AI-Assisted Endoscopic Ultrasonography Program for the Detection of Solid Pancreatobiliary Lesions: A Prospective Multicenter Observational Study' on Feb. 1.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

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 malignancy - Malignancy Genomic information - NO

Objective: 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

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 Size - 700

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068874

Disclaimer: Curated by HT Syndication.