Automated Reporting System for Biliopancreatic Endoscopic Ultrasound
Development and Prospective Multicenter Validation of an Automated Reporting System for Biliopancreatic Endoscopic Ultrasound
This study aims to develop and prospectively validate an automated reporting system to generate structured preliminary biliopancreatic EUS reports using information collected before and during EUS examinations. System development will be completed before prospective validation, and patients included in system development will be separate from those enrolled in prospective validation.
The prospective multicenter validation will enroll 420 adults undergoing EUS for suspected or confirmed biliopancreatic disease. Each patient will contribute only the first eligible EUS examination. The primary endpoint is the difference in clinical acceptance rates between system-generated preliminary reports and independently prepared manual preliminary reports. Non-inferiority will be assessed using a predefined margin.
A nested endosonographer-reporting substudy will also compare completion time and quality between final reports prepared by endosonographers with and without assistance of a system-generated preliminary report. The study will assess the ability of automated reporting to support accurate and efficient EUS reporting while routine clinical care remains unchanged.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study aims to develop and validate an automated reporting system which will generate structured preliminary reports based on preprocedural clinical data, the endosonographer's speech during EUS, EUS videos, and EUS procedural records. System development will be completed before prospective validation, using a dataset separated from the prospective validation cohort.
The prospective multicenter validation will enroll 420 adults undergoing EUS for suspected or confirmed biliopancreatic diseases. Each patient will contribute only the first eligible EUS examination as the index EUS examination. For each index examination, the automated reporting system will generate a system-generated preliminary report, while the examining endosonographer will independently generate the manual preliminary report without AI assistance. Additionally, speech-only preliminary reports and video-only preliminary reports will be generated to explore the contribution of different data inputs.
Each report will be independently assessed by two EUS experts blinded to the report source. Disagreements between the two assessors will be adjudicated by a third expert. Significant clinical corrections are defined as corrections to errors or omissions that could affect lesion localization, diagnosis, or subsequent clinical management; word and format changes alone do not qualify as significant clinical corrections. Clinical acceptance rate is defined as the proportion of all reports generated for enrolled patients that were accepted without significant clinical corrections. The primary endpoint is the difference in clinical acceptance rates between the system-generated preliminary report and the manual preliminary report of the same patient.
Additionally, a predefined nested endosonographer-reporting substudy will use the same cases to compare completion time and quality between final reports prepared by endosonographers with and without assistance of a system-generated preliminary report. Reporting tasks will be randomly assigned to endosonographers. This substudy will evaluate whether the automated reporting system can improve reporting efficiency while maintaining final report quality.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Zhen Li
- Номер телефона: 86+18560086106
- Электронная почта: qilulizhen@sdu.edu.cn
Места учебы
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Shandong
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Jinan, Shandong, Китай, 250012
- Qilu Hospital of Shandong University
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Контакт:
- Zhen Li
- Номер телефона: 86+18560086106
- Электронная почта: qilulizhen@sdu.edu.cn
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adults undergoing EUS for suspected or confirmed biliopancreatic disease at participating hospitals.
Описание
Inclusion Criteria:
- Patients aged ≥ 18years;
- Patients undergoing EUS for suspected or confirmed biliopancreatic disease;
- Patients who voluntarily sign the informed consent.
Exclusion Criteria:
- Patients who are unable to complete standard scanning due to gastrointestinal obstruction or other reasons;
- Patients who underwent surgical treatment or anatomical alterations of the pancreas due to lesions in other thoracic and/or abdominal organs, as well as patients with congenital anatomical abnormalities;
- Patients undergoing EUS primarily for therapeutic purpose such as drainage.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Adults undergoing biliopancreatic endoscopic ultrasound
Adults undergoing EUS for suspected or confirmed biliopancreatic diseases will participate in this study. Each patient provides only the first eligible EUS examination for a prospective validation of the automated reporting system. |
The system that integrates preprocedural clinical data, the endosonographer's speech during EUS, EUS videos, and EUS procedural records to generate a system-generated preliminary report. The system-generated preliminary report is generated for research validation after the routine EUS examination and is compared with the endosonographer's independent manual preliminary report. The system does not determine the patient's clinical care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Difference in clinical acceptance rates between system-generated and manual preliminary reports
Временное ограничение: Preliminary reports from the index EUS examination; assessment within 60 days after EUS.
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The within-patient paired difference in clinical acceptance rates, calculated as the rate for system-generated preliminary reports minus that for independently written manual preliminary reports. A report is accepted if it requires no significant clinical corrections-corrections to errors or omissions that could affect lesion localization, diagnosis or clinical management. Failed or blank system-generated reports are classified as not accepted. Non-inferiority is established if the lower limit of the two-sided 95% confidence interval is greater than -5 percentage points. |
Preliminary reports from the index EUS examination; assessment within 60 days after EUS.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Completeness of the system-generated preliminary reports
Временное ограничение: Index EUS examination; report assessment within 60 days.
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In the prospective paired validation, completeness is the proportion of applicable, reference-confirmed items correctly documented in each system-generated preliminary report. Items cover actual examination extent, organ findings, lesion descriptions, and sampling records. |
Index EUS examination; report assessment within 60 days.
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Number of significant clinical report corrections
Временное ограничение: Index EUS examination; report assessment within 60 days.
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In the prospective paired validation, the number of significant clinical corrections required per system-generated preliminary report will be assessed. Reductions and additions relative to the independent manual preliminary report will also be reported. |
Index EUS examination; report assessment within 60 days.
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Reporting time of the system-generated preliminary report
Временное ограничение: During the first automated report-generation task for the index EUS examination, within 30 days after EUS.
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In the prospective paired validation, time is measured from submission of all required inputs-including preprocedural clinical data, the endosonographer's speech, EUS videos, and EUS procedure records-to availability of the first system-generated preliminary report. Failed generation will be reported separately. |
During the first automated report-generation task for the index EUS examination, within 30 days after EUS.
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Reporting time of the manual preliminary report
Временное ограничение: During the routine reporting session immediately after the index EUS examination, up to 60 days
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Description: In the prospective paired validation, time is measured from the endosonographer beginning routine report preparation to submission of the independent manual preliminary report, without AI assistance. |
During the routine reporting session immediately after the index EUS examination, up to 60 days
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Difference in final report completion time with versus without AI assistance
Временное ограничение: During the assigned reporting tasks for each index EUS examination, up to 60 days
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In the randomized endosonographer-reporting substudy, the within-case difference in total time to complete a final report is calculated as unassisted time minus assisted time. Total time includes review of source materials, report generation waiting time where applicable, writing, and verification. This outcome will be formally tested only if non-inferiority of the primary outcome is established. |
During the assigned reporting tasks for each index EUS examination, up to 60 days
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Quality of final reports in the endosonographer-reporting substudy
Временное ограничение: Final reports from the assigned reporting tasks for each index EUS examination; assessment within 60 days after EUS.
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In the randomized endosonographer-reporting substudy, the proportion of final reports accepted without significant clinical corrections will be assessed separately for reports completed with and without access to the system-generated preliminary report. Completeness and clinically important errors and omissions will also be reported. |
Final reports from the assigned reporting tasks for each index EUS examination; assessment within 60 days after EUS.
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Figueroa RL, Zeng-Treitler Q, Kandula S, Ngo LH. Predicting sample size required for classification performance. BMC Med Inform Decis Mak. 2012 Feb 15;12:8. doi: 10.1186/1472-6947-12-8.
- Nam JM. Establishing equivalence of two treatments and sample size requirements in matched-pairs design. Biometrics. 1997 Dec;53(4):1422-30.
- Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat. 1999 May;9(2):241-51. doi: 10.1081/BIP-100101174.
- You H, Tao X, Dong Z, Li Y, Huang L, Li J, Du H, Deng M, Wu Z, Tan X, Yang T, Liu J, Yu H. Artificial intelligence assistance narrows the experience gap in endoscopic reporting of gastric lesions: a prospective clinical trial. Surg Endosc. 2026 Feb;40(2):1651-1660. doi: 10.1007/s00464-025-12410-z. Epub 2025 Dec 4.
- Tango T. Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Stat Med. 1998 Apr 30;17(8):891-908. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-b.
- Jiang R, Chen B, Dong Z, Zeng X, You H, Li Y, Deng Y, Mu G, Wang J, Huang L, Li J, Cheng D, Zhou W, Yu H. Domain specific multimodal large language model for automated endoscopy reporting with multicenter prospective validation. NPJ Digit Med. 2026 Mar 28;9(1):394. doi: 10.1038/s41746-026-02569-7.
- Li X, Yao L, Wu H, Tan W, Zhou W, Zhang J, Dong Z, Ding X, Yu H. A deep learning-based, real-time image report system for linear EUS. Gastrointest Endosc. 2025 Jun;101(6):1166-1173.e11. doi: 10.1016/j.gie.2024.10.030. Epub 2024 Oct 19.
- Bonmati E, Hu Y, Grimwood A, Johnson GJ, Goodchild G, Keane MG, Gurusamy K, Davidson B, Clarkson MJ, Pereira SP, Barratt DC. Voice-Assisted Image Labeling for Endoscopic Ultrasound Classification Using Neural Networks. IEEE Trans Med Imaging. 2022 Jun;41(6):1311-1319. doi: 10.1109/TMI.2021.3139023. Epub 2022 Jun 1.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2026SDU-QILU-10
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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