Using saline injections to improve ultrasound diagnosis of early esophageal cancer
Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer
This study is testing if using saline injections during an ultrasound can help doctors better tell apart early stages of esophageal cancer to avoid unnecessary surgeries for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06022978 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of submucosal saline injection (SSI) followed by endoscopic ultrasound (EUS) to enhance the diagnostic accuracy for distinguishing between T1a and T1b stages of esophageal squamous cell carcinoma (ESCC). The study aims to provide a less invasive alternative to diagnostic endoscopic resection, which is currently recommended but may not be optimal for all patients. By improving the differentiation of cancer stages, the trial seeks to help patients avoid unnecessary invasive procedures. The approach has shown promise in previous trials, indicating potential for broader application in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed esophageal squamous cell carcinoma who are eligible for surgical intervention.
Not a fit: Patients with advanced stages of esophageal cancer (T2, T3, or T4) or those unable to tolerate endoscopic procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could reduce the need for invasive diagnostic procedures in patients with early esophageal cancer.
How similar studies have performed: Previous studies have indicated that submucosal saline injection can significantly improve diagnostic accuracy, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Cancer center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jian-jun Li, M.D. — Sun Yat-sen University
- Study coordinator: Jian-jun Li, M.D.
- Email: lijj@sysucc.org.cn
- Phone: 86-2087342822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.