A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Phase 3
- Conditions
- superficial esophageal cancer
- Registration Number
- JPRN-UMIN000024080
- Lead Sponsor
- Shizuoka Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 241
Inclusion Criteria
Not provided
Exclusion Criteria
1) Treatment for gastric lesions the same day. 2) The predicted line of mucosal incision is on the previous esophageal ESD. 3) Stenosis due to the previous esophageal ESD. 4) Status after radiation or surgery for esophageal cancer. 5) Severe psychiatric disease. 6) Infectious disease with systemic therapy indicated. 7) Women during pregnancy or breastfeeding. 8) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 9) Unsuitable patient for clinical trial judged by clinicians' view.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ESD procedure time
- Secondary Outcome Measures
Name Time Method ESD procedure time according to the location of the lesion, the circumference, and tumor size; the rate of conversion case from conventional ESD to counter-traction ESD; procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa; damage of specimen caused by counter-traction; en bloc resection rate; complete en bloc resection rate; serious adverse events; factors related to technical difficulty