early gastric,esopahgeal and rectal cancer
Conditions
Interventions
Endoscopic submucosal dissection
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Depth of invasion was limited to the mucosa or thin layer of submucosa (evaluated by endoscopy and /or endoscopic ultrasonography). (2) N0M0 eavluated by CT scan (if submucosal invasion was suspected). (3) Performance status(ECOG) is 0 or 1. (4) fulfill all the criteria indicated below (within 30 days before treatment, ULN: upper limit of the institution). i) white blood cell count no fewer than 3000/mm3 no more than 10000/mm3 ii) hemoglobin more than 9.0 g/dl(No blood transfusion was done within 14 days before treatment). iii) platelet count more than 100,000/mm3 iv) GOT less or equal ULN X2.5 v) GPT less or equal ULN X2.5 vi) T-Bil less or equal 3.0mg/ml vi) serum creatinine less or equal 2.0mg/ml (5) Written informed consent is essential.
Exclusion criteria
Exclusion criteria: (1) Cases with the component of poorly differetiated carcinoma in the biopsy specimen. (2) Cases with active multiple cancers. (3) Cases with severe complication.(i.e., decompensated liver cirrhosis, severe ischemic heart disease and renal failure, poorly-controlled diabetes mellitus, chronic respiratory failure requiring for continuous oxygen administration, Discontinuation of anticoagulant therapy can not be allowed). (4) Woman in pregnancy (or woman of child bearing potential) and breast-feeding woman. (5) Cases with uncontrolled psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of this study is to evaluate the operation time of submucosal dissection using new device. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) enbloc resection rate 2) safety | — |
Countries
Japan
Outcome results
None listed