Submucosal Saline Injection Followed by Endoscopic Ultrasound

Study Overview
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Brief Summary
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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.

Official Title
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Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Submucosal Saline Injection
* Procedure: Blue laser Imaging and Magnifying Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EUS only<br>The enrolled patients will accept ordinary EUS only. | |
| Experimental: EUS+SSI<br>The enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed. | Procedure: Submucosal Saline Injection<br>* 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.<br>|
| Experimental: BLI+ME/EUS+SSI<br>The enrolled patients will be accepted ordinary endoscope using blue laser Imaging and magnified ensocope system(BLI+ME), firstly. If B3 type intra pillary capillary loops (IPCL) was observed, then the procedure would be finished (no EUS or EUS+SSI) . If B1 or B2 type IPCL was observed, then EUS+SSI would be performed. | Procedure: Submucosal Saline Injection<br>* 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.<br>Procedure: Blue laser Imaging and Magnifying Endoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic 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. | Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Submucosal Saline Injection, Endoscopic Ultrasound, Early Esophageal Cancer, Staging