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Submucosal Saline Injection Followed by Endoscopic Ultrasound

NCT06022978 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Sichuan Cancer Hospital and Research Institute

    collaborator OTHER

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jian-jun Li, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022978 on ClinicalTrials.gov