early gastric cancer
Conditions
Interventions
Control ESD
O-CTM ESD
Sponsors
Aichi cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are at least 20 years old. 2) Patients with ECOG-PS 0,1. 3) Patients who have obtained written consent from the patient. 4) Patients whose major organ functions (bone marrow, heart, liver, lungs, kidneys, etc.) are preserved. 5) Neoplastic lesions are defined as lesions diagnosed as adenoma on biopsy prior to ESD or gastric cancer, and the following lesions listed in the ESD/EMR Guidelines for Gastric Cancer (2nd Edition). i) UL0 gross intramucosal carcinoma (cT1a) of 2 cm or less in length, differentiated carcinoma ii) cT1a, differentiated carcinoma of UL0 greater than 2 cm in length iii) cT1a, differentiated carcinoma in UL1 with a diameter of 3 cm or less iv) cT1a, undifferentiated carcinoma of UL0 less than 2 cm in length
Exclusion criteria
Exclusion criteria: 1) Postoperative gastric cases. 2) Patients in which the lesion is in the vicinity of a scar from a previous endoscopic procedure. 2) Patients with concurrent multiple lesions and multiple lesions to be resected in a single ESD. 3) Patients who have been previously enrolled in this study. 4) Patients deemed inappropriate for this study by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| procedure time | — |
Secondary
| Measure | Time frame |
|---|---|
| Resection speed, R0 resection rate, En bloc resection rate, Adverse events, percentage of surgeon change from non-expert to expert, percentage of change from O-CTM to control method. | — |
Countries
Japan
Contacts
Public ContactKeisaku Yamada
Aichi cancer center Endscopy
Outcome results
None listed