Surgicel® Fibrillar for Delayed Bleeding After ESD

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01758965
Study type	Interventional
Source	Soonchunhyang University Hospital
Contact
Status	Completed
Phase	N/A
Start date	December 2012
Completion date	December 2013

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