ESI With EUS to Differentiate T3 and T4 ESCC (ESI)
Extraesophageal Saline Injection Combined With EUS to Differentiate Between T3 and T4 Stage Esophageal Squamous Cell Carcinoma - A PhaseⅠTrial
研究概览
详细说明
Esophageal cancer (EC) is one of the most common malignant tumors in the world, and China has the highest incidence of esophageal squamous cell carcinoma (ESCC).According to the TNM staging system of the Union for International Cancer Control (UICC) (7th Edition, 2012), EC invades the esophageal adventitia at the T3 stage; invades the pleura, pericardium and diaphragm at the T4a stage; and involves adjacent vital organs (mainly the thoracic aorta, aortic arch, trachea, tracheal bifurcation, and spine) at the T4b stage.It is considered that T3- and T4a-stage tumors can be surgically resected, while tumors at the T4b stage are not suitable for surgical resection.Therefore, it is important for physicians and patients to know whether the tumor has metastasized to adjacent organs before considering resection. The preoperative stage is unclear in many cases of progressive disease and the involvement of vital organs is only discovered by exploratory thoracotomy, because of which the resection may need to be terminated prematurely, leading to unnecessary injuries.Therefore, accurate preoperative staging of EC, especially during the later stages, is important for deciding the appropriate therapeutic option and evaluation of the prognosis.
The imaging methods used for preoperative staging of EC include endoscopic ultrasonography (EUS). However, EUS has poor accuracy in advanced ESCC, especially in T3 and T4 stage ESCC. Therefore, it is necessary to improve the preoperative accuracy of EUS for advanced EC.
Since extraesophageal space contains loose connective tissue and saline can permeate into extraesophageal space and separate esophagus from adjacent organ; furthermore, saline serves as an EUS contrast agent (negative) and is detected by EUS.Therefore, we envisaged that if saline is directly injected into extraesophageal space, the separation between the esophageal adventitia and its adjacent organs (especially the thoracic aorta, arcus aortae, and tracheal bifurcation) can be observed by EUS. In our recent experiment in canine model, guided by EUS,extraesophageal saline injection was successfully conducted and saline separated esophageal adventitia from adjacent organs including thoracic aorta, arcus aortae, trachea and bronchial bifurcation without any complication.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
A)Age ranges 18-65 years old, no gander limited;
B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy;
C)Patients who agree to accept esophagectomy;
D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery;
E)Patients who understand the study, are willing to join this study and sign consent inform;
Exclusion Criteria:
- Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS;
- Patients cannot tolerate endoscopy and esophagectomy with various reasons;
- Patients who have distant metastatic disease or multiple source of malignant tumor;
- Patients with blood coagulation disorder;
- Patients don't accept endoscopic or surgical resection subsequently;
- Patients with poor compliancy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Extraesophageal saline injection (ESI)
Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively
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The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with adverse events
大体时间:10 days
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Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.
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10 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI
大体时间:30 minutes
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30 minutes
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合作者和调查者
调查人员
- 首席研究员:Jian-jun Li, MD & PhD、Sun Yat-sen University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ESI-2013
- 2012-FXY-006 (其他标识符:The ethic committee of Sun Yat-sen University Cancer Center)
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