colorectal tumor colorectal tumor
Conditions
Interventions
SO clip use
Sponsors
Taki Shinya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 over 20 years old 2 colorectal tumor that is ESD-adaptive by lower gastrointestinal endoscopy in accordance with the 2014's colorectal ESD / EMR guidelines (regardless of size,form,circumference,fibrosis) 3 performance status 0-3 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 neuroendocrine tumor 3 whole invisible tumor 4 tumor involving in anal, ileum end, appendix vermiformis, diveculum 5 over two colorectal lesions which are adaptive to ESD 6 easy bleeding( Plt<50000uL) 7 Patients taking two or more antiplatelet agents or anticoagulants (excluding warfarin) that cannot be withdrawn, or patients taking warfarin with a PT-INR of 2.6 (PT-INR 3.0 if taken after mitral valve replacement surgery) or higher. 8 severe disease in other organs by ASA classification over class 4 9 pregnancy 10 any other reasons for ineligibility according to investigator judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| procedure time | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 en bloc resection rate 2 curative resection rate 3 complications associated with the procedure (intraoperative perforation , delayed perforation , afterbleeding , Post ESD Electrocoagulation Syndrome(PECS). 4 time from starting traction by SO clip to completion of submucosal dissection in test group 5 rate of conversion (cases requiring SO clip in standard group and unnecessary SO clip in test group) 6 rate of adverse events | — |
Contacts
Public ContactShinya Taki
Wakayama Medical University Hospital
Outcome results
None listed