A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumor
Phase 3
- Conditions
- early colon tumor
- Registration Number
- JPRN-UMIN000039583
- Lead Sponsor
- Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
Not provided
Exclusion Criteria
1) Past history of colorectomy 2) lesion on preoperative scar (EMR or ESD) 3)Familial adenomatous polyposis 4) Inflamatory bowel disease 5)Infectious disease with systemic therapy indicated. 6) Patints have difficulty taking bowel preparation 7) Women during pregnancy or breast-feeding 8) Patients with serious comorbidities 9)Patients who did not agree to participate in this clinical trial 10)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 1,2,3)ESD procedure time according to the location of the lesion, Macroscopic type, traction type 4) the rate of conversion case from conventional ESD to counter-traction ESD 5,6,7) procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa 8)damage of specimen caused by counter-traction 9)en bloc resection rate 10)complete en bloc resection rate 11) serious adverse events 12) the rate of snaring or Hybrid ESD due to difficulty of ESD