Surgicel® Fibrillar for Delayed Bleeding After ESD

Not Applicable

Completed

• Conditions: Benign Neoplasm of Stomach; Malignant Neoplasm of Stomach
• Interventions: Other: H2RA and surgicel; Other: PPI

• Registration Number: NCT01758965
• Lead Sponsor: Soonchunhyang University Hospital

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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination therapy of H2RA and surgicel	H2RA and surgicel	H2RA and surgicel
Monotherapy of PPI	PPI	PPI

Primary Outcome Measures

Name	Time	Method
Delayed bleeding rate after ESD	1 year

Trial Locations

Locations (1)

Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of