Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blue laser Imaging and Magnifying Endoscopy | Procedure | — | UNRESOLVED |
| Submucosal Saline Injection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- EUS only
- description
- The enrolled patients will accept ordinary EUS only.
- type
- EXPERIMENTAL
- label
- EUS+SSI
- description
- The enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed.
- interventionNames
- Procedure: Submucosal Saline Injection
- type
- EXPERIMENTAL
- label
- BLI+ME/EUS+SSI
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available