Surgicel® Fibrillar for Delayed Bleeding After ESD
Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
1 other identifier
interventional
146
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 27, 2012
CompletedFirst Posted
Study publicly available on registry
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 13, 2014
May 1, 2014
1 year
December 27, 2012
May 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Delayed bleeding rate after ESD
1 year
Study Arms (2)
combination therapy of H2RA and surgicel
EXPERIMENTALH2RA and surgicel
Monotherapy of PPI
EXPERIMENTALPPI
Interventions
combination therapy of H2RA and surgicel
Eligibility Criteria
You may qualify if:
- ESD for gastric dysplasia or early gastric cancer
You may not qualify if:
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Anti-platelet agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Bucheon-si, Gyeonggi-do, 420-767, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 27, 2012
First Posted
January 1, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 13, 2014
Record last verified: 2014-05