Traction method versus conventional endoscopic submucosal dissection for gastric epithelial neoplasms
Phase 3
Recruiting
- Conditions
- Gastric epithelial neoplasia
- Registration Number
- JPRN-UMIN000044450
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1)tumor suspected of deep submucosal invasion 2)tumor diagnosed as not gastric epithelial tumor pathologically 3)whole invisible tumor 4)tumor crossing the esophagogastric junction or the pylorus ring 5)ESD management of over double tumor 6)history of gastrectomy or reconstructive surgery of the gastric tract 7)easy bleeding 8)using over two antiplatelet or an anticoagulant medication 9)severe disease in other organs by ASA classification over class 4 10)pregnancy 11)any other reasons for ineligibility to investigator judgement
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)ESD procedure time according to the proficiency of the operator(trainee or expert),tumor size ,the location of the lesion, the presence of ulcer findings and institutions 2)Equipping time of Endo Trac 3)Procedure time from starting traction by Endo Trac to complete 4)Clip slip-off rate during Endo Trac ESD ,number of Endo Trac used 5)Conversion rate 6)Traction-related damage rate to specimen 7)Histologic evaluation(en bloc resection rate, curative resection rate, depth of tumor ,size of specimen and tumor) 8)Adverse events