A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer
Phase 2
- Conditions
- Early esophageal and gastric cancer
- Registration Number
- JPRN-UMIN000004941
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
Not provided
Exclusion Criteria
1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Women during pregnancy or breast-feeding. 3) Psychosis. 4) Systemic steroids medication. 5) Active bacterial or fungous infection. 6) History of myocardial infarction or unstable angina pectoris within three months. 7) Uncontrollable hypertension. 8) Uncontrollable diabetes mellitus or administration of insulin. 9) Severe respiratory disease requiring continuous oxygen therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of serious adverse events related to ESD
- Secondary Outcome Measures
Name Time Method Proportion of en-bloc resection, Adverse events