Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer
This study is currently recruiting participants.
Verified March 2012 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Jian-jun Li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01555801
First received: February 29, 2012
Last updated: March 14, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Device: submucosal injection needle ; EUS Device: ordinary endosonography(EUS) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer |
Resource links provided by NLM:
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- Sensitivity [ Time Frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days ] [ Designated as safety issue: No ]As well as sensitivity described above.
- Diagnostic accuracy [ Time Frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days ] [ Designated as safety issue: No ]As well as sensitivity described above.
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Submucosal injection combining with 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.
|
Device: submucosal injection needle ; EUS
The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
Other Names:
|
|
Placebo Comparator: 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.
|
Device: ordinary endosonography(EUS)
These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
Other Name: EUS:Olympus,UM2000
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555801
Contacts
| Contact: Jian-jun Li, M.D. Ph.D. | 86-2087343381 | lijj@sysucc.org.cn |
Locations
| China, Guangdong | |
| cancer center, Sun Yat-sen University | Recruiting |
| Guangzhou city, Guangdong, China, 510080 | |
| Contact: Jian-jun Li, M.D. Ph.D 86-2087343381 lijj@sysucc.org.cn | |
| Principal Investigator: Jian-jun Li, M.D. Ph.D. | |
Sponsors and Collaborators
Sun Yat-sen University
Investigators
| Principal Investigator: | Jian-jun Li, M.D. | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Jian-jun Li, Associate Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01555801 History of Changes |
| Other Study ID Numbers: | 112273, 1122 |
| Study First Received: | February 29, 2012 |
| Last Updated: | March 14, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Sun Yat-sen University:
|
esophageal cancer early cancer ultrasonography (EUS) stage |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013