An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The accuracy of iEUS-PCL for pancreatic cystic lesions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients with no prior history of treatment for pancreatic lesions.
排除标准
- •Patients with absolute contraindications to EUS examination.
- •Pregnancy or lactating.
- •Uncorrectable coagulopathy (PTT>50 seconds or INR>1.5) and/or uncorrectable thrombocytopenia(platelet count<50×109/L).
- •Upper gastrointestinal obstruction.
- •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 who have undergone biliary/pancreatic duct stent placement.
- •Patients who refuse to sign the informed consent.
研究组 & 干预措施
Patients undergoing EUS
Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations are eligible upon agreement to participate in the research and voluntary signing of the informed consent.
干预措施: iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion) (Device)
结局指标
主要结局
The accuracy of iEUS-PCL for pancreatic cystic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the accuracy of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The sensitivity of iEUS-PCL for pancreatic cystic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the sensitivity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The specificicy of iEUS-PCL for pancreatic cystic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the specificity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The postive predictive value of iEUS-PCL for pancreatic cystic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the postive predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The negative predictive value of iEUS-PCL for pancreatic cystic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the negative predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
次要结局
- Comparison of the accuracy between iEUS-PCL and endosonographers(During procedure)
- Comparison of the sensitivity between iEUS-PCL and endosonographers(During procedure)
- Comparison of the specificity between iEUS-PCL and endosonographers(During procedure)
- Comparison of the postive predictive value between iEUS-PCL and endosonographers(During procedure)
- Comparison of the negative predictive value between iEUS-PCL and endosonographers(During procedure)