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Surgicel® Fibrillar for Delayed Bleeding After ESD

This study has been completed.
Information provided by (Responsible Party):
Su Jin Hong, Soonchunhyang University Hospital Identifier:
First received: December 27, 2012
Last updated: May 12, 2014
Last verified: May 2014
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

Condition Intervention
Benign Neoplasm of Stomach
Malignant Neoplasm of Stomach
Other: PPI
Other: H2RA and surgicel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study

Resource links provided by NLM:

Further study details as provided by Su Jin Hong, Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Delayed bleeding rate after ESD [ Time Frame: 1 year ]

Enrollment: 146
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: combination therapy of H2RA and surgicel
H2RA and surgicel
Other: H2RA and surgicel
combination therapy of H2RA and surgicel
Experimental: Monotherapy of PPI
Other: PPI
monotherapy of PPI

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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

  • Coagulopathy: liver cirrhosis, thrombocytopenia
  • Anti-platelet agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT01758965

Korea, Republic of
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
  More Information

Responsible Party: Su Jin Hong, MD, PhD, Soonchunhyang University Hospital Identifier: NCT01758965     History of Changes
Other Study ID Numbers: MD_SCHBC_IRB_2012-06
Study First Received: December 27, 2012
Last Updated: May 12, 2014

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on May 25, 2017