Surgicel® Fibrillar for Delayed Bleeding After ESD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Su Jin Hong, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01758965
First received: December 27, 2012
Last updated: May 12, 2014
Last verified: May 2014
  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
Benign Neoplasm of Stomach
Malignant Neoplasm of Stomach
Other: PPI
Other: H2RA and surgicel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Soonchunhyang University Hospital:

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

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
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
  Eligibility

Ages Eligible for Study:   20 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
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: May 12, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Hemorrhage
Stomach Neoplasms
Brain Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014