Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Device: submucosal injection needle ; EUS; Device: ordinary endosonography(EUS)

• Registration Number: NCT01555801
• Lead Sponsor: Sun Yat-sen University

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Submucosal injection combining with EUS	submucosal injection needle ; EUS	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.
ordinary endosonography(EUS)	ordinary endosonography(EUS)	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

cancer center, Sun Yat-sen University; 🇨🇳 Guangzhou city, Guangdong, China