An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography

Обзор

The aim of this study is to develop and validate an artificial intelligence system named iEUS-PCL (intelligent endoscopic ultrasound system-pancreatic cystic lesions） for detecting and multimodal, multi-class diagnosing pancreatic cystic lesions (PCL) during endoscopic ultrasound (EUS) examination.

Подробное описание

This multicenter, prospective cohort study aims to develop and validate a multimodal artificial intelligence system named iEUS-PCL for the detection and differential diagnosis of PCL. The model was developed based on retrospectively collected EUS images, EUS features, clinical data and radiological imaging features of patients who underwent EUS examination. The diagnostic performance of iEUS-PCL will be evaluated prospectively in real-time EUS videos and compared with endosonographers' performance.

Вмешательства

• Устройство iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion)
  The iEUS-PCL will automatically detect pancreatic cystic lesions and integrate the patients' EUS images, EUS features, clinical data and radiological imaging features to perform three classification tasks: 1. binary classification: benign/malignant lesions; 2. binary classification: mucinous/non-mucinous lesions; 3. four-category classification: intraductal papillary mucinous neoplasm/ mucinous cystic neoplasm/ serous cyst neoplasm/ pancreatic cyst.

Первичные конечные точки

• The accuracy of iEUS-PCL for pancreatic cystic lesions [Срок оценки: During procedure]
• The sensitivity of iEUS-PCL for pancreatic cystic lesions [Срок оценки: During procedure]
• The specificicy of iEUS-PCL for pancreatic cystic lesions [Срок оценки: During procedure]
• The postive predictive value of iEUS-PCL for pancreatic cystic lesions [Срок оценки: During procedure]
• The negative predictive value of iEUS-PCL for pancreatic cystic lesions [Срок оценки: During procedure]

Вторичные конечные точки (5)

• Comparison of the accuracy between iEUS-PCL and endosonographers [Срок оценки: During procedure]
• Comparison of the sensitivity between iEUS-PCL and endosonographers [Срок оценки: During procedure]
• Comparison of the specificity between iEUS-PCL and endosonographers [Срок оценки: During procedure]
• Comparison of the postive predictive value between iEUS-PCL and endosonographers [Срок оценки: During procedure]
• Comparison of the negative predictive value between iEUS-PCL and endosonographers [Срок оценки: During procedure]

Критерии участия

Критерии включения

\- 1. Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations, and who agree to participate in the research and voluntarily sign the informed consent.

2\. Patients with no prior history of treatment for pancreatic lesions.

Критерии исключения

\- 1. Patients with absolute contraindications to EUS examination. 2. Pregnancy or lactating. 3. Uncorrectable coagulopathy(PTT>50 seconds or INR>1.5) and/or uncorrectable thrombocytopenia(platelet count<50×109/L). 4. Upper gastrointestinal obstruction. 5. 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.

6\. Patients who have undergone biliary/pancreatic duct stent placement. 7. Patients who refuse to sign the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Публикации

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Идентификаторы

NCT: NCT07543263 · 2026-SDU-QILU-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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