A Prospective, Multicenter Clinical Study on the Diagnostic Value of "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 157
- 主要终点
- positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis
研究概览
简要总结
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
详细描述
When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.
The etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. Currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum CA19-9), imaging, and endoscopic retrograde cholangiopancreatography (ERCP). However, these methods have limitations, such as the limited specificity and sensitivity of CA19-9 and the indirect imaging of ERCP after contrast agent filling. Therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. This study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);
排除标准
- •Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;
- •Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;
结局指标
主要结局
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis
时间窗: 1 years
The results are compared with pathological results of surgical specimens
positive rate of cholangioscopy-guided forceps biopsy
时间窗: 1 years
The results are compared with pathological results of surgical specimens
次要结局
- adverse event rate of each individual technique(1 years)
- the positive rate of biopsy(1 years)