Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
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
  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:
  • submucosal injection needle:Olympus,NM-20K-0423;
  • EUS:Olympus,UM2000
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014