1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
- Anti-platelet agents
2. Method
(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group:
monotherapy with PPI 3. Sample size : 172 4. Result
1. Primary endpoint: rate of delayed bleeding after ESD
2. Secondary endpoint: follow-up hemoglobin after ESD
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Delayed bleeding rate after ESD
1 year
Yes
United States: Food and Drug Administration
MD_SCHBC_IRB_2012-06
NCT01758965
December 2012
Name | Location |
---|