Clinical trial · Interventional
ESI With EUS to Differentiate T3 and T4 ESCC
Extraesophageal Saline Injection Combined With EUS to Differentiate Between T3 and T4 Stage Esophageal Squamous Cell Carcinoma - A PhaseⅠTrial
- 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)
By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be separate from the adjacent organs.The space between esophagus and adjacent organs can be detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extraesophageal saline injection (ESI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Extraesophageal saline injection (ESI)
- description
- Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively
- interventionNames
- Device: Extraesophageal saline injection (ESI)
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 10 days
- description
- Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.
Secondary outcomes (1)
- measure
- Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: A)Age ranges 18-65 years old, no gander limited; B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy; C)Patients who agree to accept esophagectomy; D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery; E)Patients who understand the study, are willing to join this study and sign consent inform; Exclusion Criteria: 1. Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS; 2. Patients cannot tolerate endoscopy and esophagectomy with various reasons; 3. Patients who have distant metastatic disease or multiple source of malignant tumor; 4. Patients with blood coagulation disorder; 5. Patients don't accept endoscopic or surgical resection subsequently; 6. Patients with poor compliancy.
References
Publications (0)
Data not yet available