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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
432
Inject 3-5 mL of saline into the submucosa within 10 minutes using a single-use 22G mucosal needle. The puncture point is located 0.5 cm from the edgeof the lesion, and the saline injection is stopped when the esophageal mucosa is elevated by approximately 1 cm.
It is a new system for image-enhanced endoscopy using laser light. By clicking a button on the endoscope only , endoscopists can electronically stain and magnify the digestive tract lesions. This system can help endoscopists observe leisons more clearly and improve diagnosic accuracy.
Cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGDiagnostic accuracy for T1a and T1b staging
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.
Time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
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