Surgicel® Fibrillar for Delayed Bleeding After ESD

Malignant Neoplasm of Stomach Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758965
• Other study ID #: MD_SCHBC_IRB_2012-06
• Status: Completed
• Phase: N/A
• First received: December 27, 2012
• Last updated: May 12, 2014
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

• Coagulopathy: liver cirrhosis, thrombocytopenia

• Anti-platelet agents

Study Design

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

Related Conditions & MeSH terms

• Benign Neoplasm of Stomach
• Malignant Neoplasm of Stomach
• Neoplasms
• Stomach Neoplasms

Intervention

Other:
• PPI
monotherapy of PPI
• H2RA and surgicel
combination therapy of H2RA and surgicel

Locations

Country	Name	City	State
Korea, Republic of	Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed bleeding rate after ESD		1 year	Yes