A randomized controlled trial comparing conventional ESD versus hybrid ESD for gastric neoplasms
Not Applicable
- Conditions
- Gastric neoplasm
- Registration Number
- JPRN-UMIN000041244
- Lead Sponsor
- Graduate School of Medicine, Kyushu University
- Brief Summary
The procedure time of H-ESD was significantly shorter than that of C-ESD (33.16 min vs 62.46 min; H-ESD/C-ESD ratio: 0.53; 95% confidence interval, 0.41-0.69; P < .0001).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
Not provided
Exclusion Criteria
-Patients with a history of gastric surgery -Patients on dialysis -Patients requiring continuous administration of heparin during perioperative period. -Contraindication with endoscopy; ileus, gastrointestinal perforation or severe respiratory/cardiac disease. -Metal allergy -Patients who are judged inappropriate by physician participating in this trial -Patients who cannot obtain informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedure time of ESD
- Secondary Outcome Measures
Name Time Method Time and speed of mucosal incision Time and speed of submucosal dissection with or without snaring En bloc and complete resection Curability judged by histological assessment of resected specimen Endoscopic procedural adverse events including intraoperative perforation, delayed perforation and delayed bleeding Degree of dissected submucosal layer before snaring Volume of injective solution Number and time of hemostasis using hemostatic device during procedure Thickness of submucosal layer in resected specimen The relationship between outcomes and morphology / location / size/ ulceration / operator's experience.