Esophageal Cancer
Conditions
Keywords
esophageal cancer, early cancer, ultrasonography (EUS), stage
Brief summary
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.
Detailed description
Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn
Interventions
DEVICEsubmucosal injection needle ; EUS
The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
DEVICEordinary endosonography(EUS)
These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days | 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. |
| Specificity | Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days | As well as sensitivity described above. |
| Diagnostic accuracy | Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days | As well as sensitivity described above. |
Countries
China
Contacts
Primary ContactJian-jun Li, M.D. Ph.D.
Outcome results
None listed