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Surgicel® Fibrillar for Delayed Bleeding After ESD

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ClinicalTrials.gov Identifier: NCT01758965
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Su Jin Hong, Soonchunhyang University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Benign Neoplasm of Stomach Malignant Neoplasm of Stomach Other: PPI Other: H2RA and surgicel Not Applicable

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  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




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


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

Inclusion Criteria:

  • ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758965


Locations
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

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
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases