Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD
- Conditions
- Colorectal tumor
- Registration Number
- JPRN-UMIN000052397
- Lead Sponsor
- TT medical center Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 270
Not provided
1) Giant lesions with a tumor diameter of 50 mm or more or more than 3/4 circumference 2) Extension into or proximity to the appendiceal orifice or diverticulum, requiring ESD treatment of the orifice or diverticular area 3) Local recurrence after endoscopic resection or postoperative anastomotic lesions 4) Colorectal cancer with inflammatory bowel disease 5) Familial adenomatous colorectal adenomatosis 6) Patients with infectious diseases requiring systemic treatment 7) Patients with serious comorbidities that make it difficult for them to participate in this study 8) Women of childbearing potential, pregnant, or lactating women 9) Positive COVID19 antigen test or PCR test, etc. in advance. No symptoms are required. 10) Other cases in which participation in this study is deemed inappropriate by the physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resection time
- Secondary Outcome Measures
Name Time Method Resection speed Number of times the device is inserted and removed Total local injection volume (volume of sodium hyaluronate solution and saline combined) Intraoperative perforation rate