Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- negative predictive value
研究概览
简要总结
In this study, a single-center, prospective, self-control, and blind design was adopted.
详细描述
It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA). First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, <90 years old 2.The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis
- •Agree to participate in this study and sign the CH-EUS informed consent form
排除标准
- •Subjects who meet any of the following criteria cannot be selected for this trial:
- •First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
- •Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
- •Blood coagulation dysfunction (platelet count <50×1012, international standardized ratio> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
- •Anesthesia assessment failed
- •Had acute pancreatitis within 2 weeks
- •Pregnancy or breastfeeding
- •Known history of allergy to sulfur hexafluoride or other components
- •Recent acute coronary syndrome or clinically unstable ischemic heart attack
- •Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.
- •Second. Disagree to participate in this study
- •Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:
- •Pancreatic disease has undergone surgery or chemotherapy beforehand
- •The patient was diagnosed with pancreatic cystic disease or duodenal stenosis
- •Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up
结局指标
主要结局
negative predictive value
时间窗: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
accuracy
时间窗: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
specificity
时间窗: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
positive predictive value
时间窗: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
the diagnosis rate of first needle aspiration
时间窗: 1 year
compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses
sensitivity
时间窗: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
次要结局
- core tissue length(1 year)