Back to resultsSurgicel® Fibrillar for Delayed Bleeding After ESD
Primary Purpose
Benign Neoplasm of Stomach, Malignant Neoplasm of Stomach
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PPI
H2RA and surgicel
Sponsored by
About this trial
This is an interventional prevention trial for Benign Neoplasm of Stomach
Eligibility Criteria
Inclusion Criteria:
- ESD for gastric dysplasia or early gastric cancer
Exclusion Criteria:
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Anti-platelet agents
Sites / Locations
- Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
combination therapy of H2RA and surgicel
Monotherapy of PPI
Arm Description
H2RA and surgicel
PPI
Outcomes
Primary Outcome Measures
Delayed bleeding rate after ESD
Secondary Outcome Measures
Full Information
NCT ID
NCT01758965
First Posted
December 27, 2012
Last Updated
May 12, 2014
Sponsor
Soonchunhyang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758965
Brief Title
Surgicel® Fibrillar for Delayed Bleeding After ESD
Official Title
Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
Anti-platelet agents
Method
(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result
Primary endpoint: rate of delayed bleeding after ESD
Secondary endpoint: follow-up hemoglobin after ESD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Neoplasm of Stomach, Malignant Neoplasm of Stomach
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combination therapy of H2RA and surgicel
Arm Type
Experimental
Arm Description
H2RA and surgicel
Arm Title
Monotherapy of PPI
Arm Type
Experimental
Arm Description
PPI
Intervention Type
Other
Intervention Name(s)
PPI
Intervention Description
monotherapy of PPI
Intervention Type
Other
Intervention Name(s)
H2RA and surgicel
Intervention Description
combination therapy of H2RA and surgicel
Primary Outcome Measure Information:
Title
Delayed bleeding rate after ESD
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ESD for gastric dysplasia or early gastric cancer
Exclusion Criteria:
Coagulopathy: liver cirrhosis, thrombocytopenia
Anti-platelet agents
Facility Information:
Facility Name
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
12. IPD Sharing Statement
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Surgicel® Fibrillar for Delayed Bleeding After ESD
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