Randomized Controlled Trial to assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms
Phase 3
- Conditions
- early gastric cancer/gastric adenoma
- Registration Number
- JPRN-UMIN000015091
- Lead Sponsor
- Graduate School of Medicine, University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
1)History of endoscopic treatment for upper GI lesion in the past 28 days. 2)With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently. 3)With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD. 4)with heparinization. 5)With an allergy to proton pomp inhibitor. 6)Pregnant or lactation woman. 7) History of myocardial infarction or unstable angina pectoris within 3 months. 8)With uncontrollable hypertension. 9)Patients whom investigators judge to be unsuitable for this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method post-ESD bleeding rate(from soon after ESD to 28 days after ESD)
- Secondary Outcome Measures
Name Time Method 1)late post-ESD bleeding rate(from meal commencement after ESD to 28 days after ESD) 2)blood transfusion rate associated with post-ESD bleeding 3)the rate of complications caused by PGA sheets or fibrin glue 4)risk factor for post-ESD bleeding 5)post-ESD bleeding rate in the patients whose resected specimen sizes are over 40mm 6)post-ESD bleeding rate in the cases where mucosal defects are shielding completely by PGA sheets 7)the rate of emergency endoscopy after ESD