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NCT06022978Recruiting

Submucosal Saline Injection Followed by Endoscopic Ultrasound

Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
Sun Yat-sen UniversityClinicalTrials.govprocedure
Study focus
Disease/Condition
Esophageal Cancer
Drug/Device/Intervention
Submucosal Saline Injection
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Sun Yat-sen University
Location
Guangzhou, China
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2021
End date
Dec 30, 2024
Enrollment
432 participants
Primary outcome

Diagnostic accuracy for T1a and T1b staging

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.

ICD-10 classifications
Carcinoma in situ: OesophagusMalignant neoplasm of oesophagusMalignant neoplasm: Middle third of oesophagusMalignant neoplasm: Overlapping lesion of oesophagusMalignant neoplasm: Upper third of oesophagus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06022978
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06022978 through Pure Global AI's free database. This phase not specified trial is sponsored by Sun Yat-sen University and is currently Recruiting. The study focuses on Esophageal Cancer. Target enrollment is 432 participants.

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