Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.
详细描述
Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old, no gender limited;
- •Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
- •Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
- •patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
- •patients who understand test purpose, volunteer to join these study and sign the consent inform.
排除标准
- •Patients with stages of T2, T3, or T4 displayed by EUS;
- •Patients who can't tolerate endoscopy and surgical treatment for various reasons;
- •Patients who have distant metastasis, or multiple source of malignant tumors;
- •Patients with blood coagulative disorder;
- •Patients don't accept the endoscopic examination or surgical treatment;
- •Patients with poor compliancy.
结局指标
主要结局
Specificity
时间窗: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
As well as sensitivity described above.
Sensitivity
时间窗: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
The stages judged from submucosal injection plus EUS or ordinary EUS will be compared with the pathological results after endoscopic or surgical resection.So the sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of either submucosal injection plus EUS or ordinary EUS for early esophageal cancer will be measured respectivly.
Diagnostic accuracy
时间窗: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
As well as sensitivity described above.
次要结局
未报告次要终点
研究者
Jian-jun Li
Associate Professor
Sun Yat-sen University