A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Phase 3
- Conditions
- clinical stage IA esphageal cancer
- Registration Number
- JPRN-UMIN000028297
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
See the datails via "URL related to results and publications" above.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 372
Inclusion Criteria
Not provided
Exclusion Criteria
1. Active infection requiring systemic therapy 2. Body temperature >= 38 degrees Celsius 3. Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding 4. Severe psychiatric disease 5. Poorly controlled hypertension 6. Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of pathological SM1 or shallower lesions in those with a diagnosis of clinical SM2 or deeper.
- Secondary Outcome Measures
Name Time Method The proportion of pathological SM2 or deeper lesions in those with a diagnosis of clinical SM1 or shallower, sensitivity, specificity, positive predictive value, negative predictive value, adverse events