early gastric cancer, early colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients who are diagnosed as early gastric cancer and early colorectal cancer and are considered as the indication of ESD treatment. 2)Provided with written informed conscent.
Exclusion criteria
Exclusion criteria: 1)Patients whose lesions are found to be outside the guideline or expanded criteria for ESD. 2)Severe fibrosis. 3)Patients with hematological abnormality. 4)Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. 5)Patients who are pregnant or lactation. 6)Patients without written informed consent. 7)Lesions which are thought to be difficult to resect by ESD because of unstable positioning of endoscope. 8)Patients who are disqualified for the study by physicians 9)Refusal of the trial entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to verify the feasibility of mucosal elevation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include the procedure time, the en bloc resection rate, the number of endoscopic device changes (endoscopic injection needle, different device), the adverse event rate such as post-operative bleeding and perforation. | — |
Countries
Japan
Contacts
Keio University, School of Medicine Cancer Center