A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissectio
Phase 1
- Conditions
- early gastric cancers
- Registration Number
- JPRN-UMIN000033988
- Lead Sponsor
- ippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) bleeding tendency 2) liver cirrhosis (Child-Pugh score: B-C) 3) chronic kidney disease on hemodialysis 4) history of endoscopic treatment 1 month prior to the current study 5) cases in which doctors in charge regarded as unsuitable to inclusion for the current study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method suture-maintenance rate on the postoperative day 3
- Secondary Outcome Measures
Name Time Method completeness of suturing, postoperative bleeding rate, postoperative minor bleeding rate, adverse events (excluding postoperative bleeding), suturing duration, postoperative bleeding rate with/without anti-thrombotic agents