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| ID | Type | Description | Link |
|---|---|---|---|
| 1122 | Registry Identifier | Jian-jun Li |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Submucosal injection combining with EUS | Experimental | The enrolled patients will be accepted submucosal injection of saline,then ultrasonography will performed(EUS+SIS group).So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) or esophagectomy. |
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| ordinary endosonography(EUS) | Placebo Comparator | The enrolled patients will accept ordinary ultrasonography .So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) , endoscopic submucosal dissection(ESD) or esophagectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| submucosal injection needle ; EUS | Device | The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | 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 |
| Specificity | As well as sensitivity described above. | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-jun Li, M.D. Ph.D. | Contact | 86-2087343381 | lijj@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian-jun Li, M.D. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cancer center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31615934 | Derived | He LJ, Xie C, Wang ZX, Li Y, Xiao YT, Gao XY, Shan HB, Luo LN, Chen LM, Luo GY, Yang P, Zeng SC, Xu GL, Li JJ. Submucosal Saline Injection Followed by Endoscopic Ultrasound versus Endoscopic Ultrasound Only for Distinguishing between T1a and T1b Esophageal Cancer. Clin Cancer Res. 2020 Jan 15;26(2):384-390. doi: 10.1158/1078-0432.CCR-19-1722. Epub 2019 Oct 15. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| ordinary endosonography(EUS) | Device | These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection. |
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| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |