Surgicel® Fibrillar for Delayed Bleeding After ESD

May 12, 2014 updated by: Su Jin Hong, Soonchunhyang University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
        • Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combination therapy of H2RA and surgicel
H2RA and surgicel
Other: H2RA and surgicel
combination therapy of H2RA and surgicel
Experimental: Monotherapy of PPI
PPI
Other: PPI
monotherapy of PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delayed bleeding rate after ESD
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD_SCHBC_IRB_2012-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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