Surgicel® Fibrillar for Delayed Bleeding After ESD

Soonchunhyang University Hospital146 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

146

Conditions

Benign Neoplasm of Stomach Malignant Neoplasm of Stomach

Interventions

PPIOTHER

monotherapy of PPI

H2RA and surgicelOTHER

combination therapy of H2RA and surgicel

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ESD for gastric dysplasia or early gastric cancer Exclusion Criteria: * Coagulopathy: liver cirrhosis, thrombocytopenia * Anti-platelet agents

Locations (1)

Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Delayed bleeding rate after ESD

Time frame: 1 year

Data from ClinicalTrials.gov

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