Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
- Conditions
- early gastric cancer, early colorectal cancer
- Registration Number
- JPRN-UMIN000018039
- Lead Sponsor
- Keio University, School of Medicine
- Brief Summary
All the lesions were successfully treated by mucosal elevation. The median resected specimen size in stomach and colorectum lesions were 37.3mm and 34.0 mm respectively. The mean procedure time in stomach and colorectum lesions were 36 min and 32.3 min respectively. The en bloc resection rates were 100% in both lesions. The median number of endoscopic device changes in stomach and colorectum lesions were three times and four times respectively. No severe adverse events were observed in both lesions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is to verify the feasibility of mucosal elevation.
- Secondary Outcome Measures
Name Time Method 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.