Surgicel® Fibrillar for Delayed Bleeding After ESD

Soon Chun Hyang University

Status: Completed

Conditions: Benign Neoplasm of Stomach; Malignant Neoplasm of Stomach

Treatments: Other: H2RA and surgicel; Other: PPI

Study type: Interventional

Funder types: Other

Identifiers

NCT01758965

MD_SCHBC_IRB_2012-06

Details and patient eligibility

About

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

Full 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

Enrollment: 146 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ESD for gastric dysplasia or early gastric cancer

Exclusion criteria

• Coagulopathy: liver cirrhosis, thrombocytopenia
• Anti-platelet agents

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

combination therapy of H2RA and surgicel

Experimental group

Description:

H2RA and surgicel

Treatment:

Other: H2RA and surgicel

Monotherapy of PPI

Experimental group

Description:

PPI

Treatment:

Other: PPI