Superficial esophageal cancer
Conditions
Interventions
Esophageal ESD with steady pressure automatically controlled endoscopy
Sponsors
Japan SPACE study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) To be diagnosed as SCC or High grade intraepithelial neoplasia by endoscopic forceps biopsy. 2) The invasion depth is diagnosed endoscopically as T1a-EP or T1a-LPM. 3) The lesion occupies less than 2/3 of the circumference of esophagus. 4) Without past history of esophagectomy. 5) Not to be involved cervical esophagus or esophago-gastro junction. 6) The age is more than 20 and less than 80. 7) PS (ECOG) is 0 or 1. 8) Not to show significant abnormality by respiratory function test. 9) Main organ function is maintained by blood sampling. 10) Written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1) To be affected infectious disease which need systemic treatment. 2) With body temperature higher than 38C 3) To have bleeding tendency. 4) Pregnancy or possibility of pregnancy or breast-feeding woman 5) Psychiatric disease 6) To be treated systemic steroid therapy 7) Unstable angina 8) Uncontrolled hypertension 9) Uncontrolled DM 10) Unable to interrupt anticoaglant for ESD 11) To be judged inapropriate to participate this trial by contact person
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse event (based on NCI-CTCAE ver. 4.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Completion rate of ESD 2) The changes of pCO2 before and after ESD 3) The changes of vital signs during ESD 4) En bloc margin negative rate of ESD 5) Procedure duration 6) Patients' subjective symptom 7) Dosage amount of sedative during ESD | — |
Countries
Japan
Contacts
Public ContactKiyokazu Nakajima
Osaka University Graduate School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed