An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- The accuracy of iEUS-SPL for solid pancreatic lesions
研究概览
简要总结
The aim of this study is to validate an artificial intelligence system named iEUS-SPL(intelligent endoscopic ultrasound system-solid pancreatic lesion) for detecting and multimodal, multi-class diagnosing solid pancreatic lesions during endoscopic ultrasound(EUS) examination.
详细描述
This is an observational study with a prospective, cohort design. We have developed an artificial intelligence system named iEUS-SPL for multimodal, multi-class diagnosing solid pancreatic lesions using endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features from retrospectively collected patients who underwent EUS. The lesion detection rate and diagnostic performance of iEUS-SPL in identifying solid pancreatic lesions will be evaluated in real-time EUS scanning videos over prospective enrolled cases.
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
- 是
入选标准
- •Patients aged ≥18 years scheduled for EUS with suspected solid pancreatic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations agree to participate in the research and be able to sign 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 solid pancreatic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations agree to participate in the research and be able to sign informed consent.
干预措施: iEUS-SPL(intelligent endoscopic ultrasound system-pancreatic solid lesion) (Device)
结局指标
主要结局
The accuracy of iEUS-SPL for solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the accuracy of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The sensitivity of iEUS-SPL for solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the sensitivity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The specificicy of iEUS-SPL for solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the specificity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The postive predictive value of iEUS-SPL for solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the postive predictive value of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The negative predictive value of iEUS-SPL for solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the negative predictive value of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
the lesion detection rate of iEUS-SPL for detecting solid pancreatic lesions
时间窗: During procedure
The primary outcome of the study is to evaluate the lesion detection rate of the iEUS-SPL in identifying the solid pancreatic lesions(defined as the number of detected lesions divided by the total number of lesions).
次要结局
- Comparison of the accuracy between iEUS-SPL and endosonographers(During procedure)
- Comparison of the sensitivity between iEUS-SPL and endosonographers(During procedure)
- Comparison of the specificity between iEUS-SPL and endosonographers(During procedure)
- Comparison of the postive predictive value between iEUS-SPL and endosonographers(During procedure)
- Comparison of the negative predictive value between iEUS-SPL and endosonographers(During procedure)