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Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity

Outcome Description:

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.

Outcome 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

Safety Issue:

No

Principal Investigator

Jian-jun Li, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

112273

NCT ID:

NCT01555801

Start Date:

February 2012

Completion Date:

September 2012

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer
  • early cancer
  • ultrasonography (EUS)
  • stage
  • Esophageal Diseases
  • Esophageal Neoplasms

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