Spots Global Cancer Trial Database for Surgicel® Fibrillar for Delayed Bleeding After ESD
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Trial Identification
Brief Title: Surgicel® Fibrillar for Delayed Bleeding After ESD
Official Title: Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
Study ID: NCT01758965
Study Description
Brief Summary: The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors
Detailed Description: 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 : 157 4. Result 1. Primary endpoint: rate of delayed bleeding after ESD 2. Secondary endpoint: follow-up hemoglobin after ESD
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Gyeonggi-do, Korea, Republic of
Contact Details
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