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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
