Esophageal CancerEUS-SSINCT06022978
Submucosal Saline Injection Followed by Endoscopic Ultrasound
A study testing Submucosal Saline Injection and Blue laser Imaging and Magnifying Endoscopy in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Submucosal Saline Injection and Blue laser Imaging and Magnifying Endoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jian-jun Li, M.D., 86-2087343381, lijj@sysucc.org.cn
Jian-jun Li, M.D.
About this study
Official title: Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
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
- Being tested
- Submucosal Saline Injection, Blue laser Imaging and Magnifying Endoscopy
- Keywords
- Submucosal Saline Injection, Endoscopic Ultrasound, Early Esophageal Cancer, Staging
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal Saline InjectionProcedure or surgery
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 EndoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS only | No intervention | The enrolled patients will accept ordinary EUS only. |
| EUS+SSI | Experimental | The enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed. Receives: Procedure: Submucosal Saline Injection |
| BLI+ME/EUS+SSI | Experimental | 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. Receives: Procedure: Submucosal Saline Injection; Procedure: Blue laser Imaging and Magnifying Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Jan 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Shandong Cancer Hospital and Institute, Xinqiao Hospital of Chongqing, Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
- Responsible party
- Principal investigator, Jian-jun Li, Sun Yat-sen University
- Investigators
- Jian-jun Li, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022978
- Sponsor's protocol ID
- FXY-068
- Acronym
- EUS-SSI
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06022978
- Acronym / sponsor ID
- EUS-SSI / FXY-068
- Conditions
- Esophageal Cancer
- Keywords
- Submucosal Saline Injection, Endoscopic Ultrasound, Early Esophageal Cancer, Staging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Shandong Cancer Hospital and Institute, Xinqiao Hospital of Chongqing, Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EUS only | No intervention | –The enrolled patients will accept ordinary EUS only. |
| EUS+SSI | Experimental | Procedure: Submucosal Saline InjectionThe enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed. |
| BLI+ME/EUS+SSI | Experimental | Procedure: Submucosal Saline Injection, Procedure: Blue laser Imaging and Magnifying EndoscopyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submucosal Saline InjectionInject 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 or surgery | BLI+ME/EUS+SSI, EUS+SSI |
| Blue laser Imaging and Magnifying EndoscopyIt 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. | Procedure or surgery | BLI+ME/EUS+SSI |
Primary outcome
Diagnostic accuracy for T1a and T1b staging
Time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-jun Li, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal Saline Injection and Blue laser Imaging and Magnifying Endoscopy in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-jun Li, M.D. (86-2087342822, lijj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for T1a and T1b staging (time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.