Submucosal Saline Injection Followed by Endoscopic Ultrasound

Esophageal Cancer Clinical Trial

— EUS-SSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022978
• Other study ID #: FXY-068
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: Jian-jun Li, M.D.
• Phone: 86-2087342822
• Email: lijj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Submucosal Saline Injection
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.
• Blue laser Imaging and Magnifying Endoscopy
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.

Locations

Country	Name	City	State
China	Cancer center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Sun Yat-sen University	Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xinqiao Hospital of Chongqing, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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