Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy for T1a and T1b staging
研究概览
简要总结
Endoscopic ultrasound (EUS) is unsatisfactory in distinguishing between T1a and T1b stage esophageal squamous cell carcinoma (ESCC). Consequently, the National Comprehensive Cancer Network guidelines recommend endoscopic resection (ER) as a diagnostic tool for substaging T1 stage ESCC. However, as an invasive approach, diagnostic ER is not an optimal approach especially for T1b cases as most of them might not be fully cured by ER. It is necessary to develop reliable and less invasive methods to distinguish between T1a and T1b stage ESCC. In our previous unicentral trial, we found that submucosal saline injection (SSI) significantly improved the diagnostic accuracy of EUS in differentiating between T1a and T1b stage ESCC. It can be used as an alternative to diagnostic ER for preoperative substaging T1 stage ESCC cases in remote regions where few endoscopists are able to perform diagnostic ER. The use of EUS and SSI would help T1b stage patients avoid invasive diagnostic ER.
Therefore, we aim to conduct a multi-center clinical trail to examine whether SSI can improve traditional EUS accuracy in distinguishing between T1a and T1b stage ESCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 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
Diagnostic accuracy for T1a and T1b staging
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 EUS or EUS+SSI or BLI+ME/EUS+SSI 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 the three groups for early esophageal cancer will be measured respectivly.
次要结局
未报告次要终点
研究者
Jian-jun Li
Professor
Sun Yat-sen University