Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.
Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
80
The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSensitivity
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.
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
Specificity
As well as sensitivity described above.
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
Diagnostic accuracy
As well as sensitivity described above.
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
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