Submucosal Saline Injection Followed by Endoscopic Ultrasound
EUS-SSI
1 other identifier
interventional
432
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedSeptember 5, 2023
August 1, 2023
4 years
August 28, 2023
August 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
EUS only
NO INTERVENTIONThe enrolled patients will accept ordinary EUS only.
EUS+SSI
EXPERIMENTALThe enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed.
BLI+ME/EUS+SSI
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Zhejiang Cancer Hospitalcollaborator
- Sichuan Cancer Hospital and Research Institutecollaborator
- Shandong Cancer Hospital and Institutecollaborator
- Xinqiao Hospital of Chongqingcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicinecollaborator
Study Sites (1)
Cancer center, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-jun Li, M.D.
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 5, 2023
Study Start
January 1, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
September 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL