Gastric epithelial neoplasia
Conditions
Interventions
Endo Trac ESD group
Conventional ESD group
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)over 20 years old 2)gastric epihelial tumor that is ESD-adaptive by endoscopy in accordance with the 2020 ESD/EMR guideline for gastric cancer 3)performance status 0-2 4)obtained written informed consent after appropriate explanation prior to study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESD procedure time | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactJun Kinoshita
Wakayama Medical University Hospital Gastroenterology
Outcome results
None listed