Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
The stages judged from submucosal injection plus EUS or ordinary EUS 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 either submucosal injection plus EUS or ordinary EUS 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
Jian-jun Li, M.D.
Sun Yat-sen University
China: Food and Drug Administration