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Trial Title: Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer

NCT ID: NCT01555801

Condition: Esophageal Cancer

Conditions: Official terms:
Esophageal Neoplasms

Conditions: Keywords:
esophageal cancer
early cancer
ultrasonography (EUS)
stage

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Intervention:

Intervention type: Device
Intervention name: submucosal injection needle ; EUS
Description: The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
Arm group label: Submucosal injection combining with EUS

Other name: submucosal injection needle:Olympus,NM-20K-0423;

Other name: EUS:Olympus,UM2000

Intervention type: Device
Intervention name: ordinary endosonography(EUS)
Description: These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
Arm group label: ordinary endosonography(EUS)

Other name: EUS:Olympus,UM2000

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

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: cancer center, Sun Yat-sen University

Address:
City: Guangzhou city
Zip: 510080
Country: China

Status: Recruiting

Contact:
Last name: Jian-jun Li, M.D. Ph.D

Phone: 86-2087343381
Email: lijj@sysucc.org.cn

Investigator:
Last name: Jian-jun Li, M.D. Ph.D.
Email: Principal Investigator

Start date: February 2012

Completion date: December 2018

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01555801

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