NCT01758965

Surgicel® Fibrillar for Delayed Bleeding After ESD

Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Benign Neoplasm of Stomach
• Malignant Neoplasm of Stomach

Interventions

Type	Name	Description
OTHER	PPI	monotherapy of PPI
OTHER	H2RA and surgicel	combination therapy of H2RA and surgicel

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-01-01
• Last updated: 2014-05-13

Locations

1 site across 1 country: South Korea