Effect of Surgicel® Fibrillar on Prevention for Ulcer Bleeding After ESD(Endoscopic Submucosal Dissection) of Gastric Epithelial Tumors

This study is currently recruiting participants.
Verified December 2013 by Soonchunhyang University Hospital
Sponsor:
Information provided by (Responsible Party):
Su Jin Hong, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01758965
First received: December 27, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Phase
Gastric Epithelial Tumors
Drug: combination with Surgicel® Fibrillar and H2 receptor antagonist
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Delayed bleeding rate after ESD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 172
Study Start Date: December 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Surgicel+H2RA, 2: PPI Drug: combination with Surgicel® Fibrillar and H2 receptor antagonist

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 : 172 4. Result

  1. Primary endpoint: rate of delayed bleeding after ESD
  2. Secondary endpoint: follow-up hemoglobin after ESD
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

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

Locations
Korea, Republic of
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Su Jin Hong, MD, PhD    +82-32-621-5087    sjhong@schmc.ac.kr   
Sub-Investigator: Jae Pil Han, MD         
Sponsors and Collaborators
Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Su Jin Hong, MD, PhD, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01758965     History of Changes
Other Study ID Numbers: MD_SCHBC_IRB_2012-06
Study First Received: December 27, 2012
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014