Back to resultsComparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
Primary Purpose
Delayed Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high dose proton pump inhibitor
H2RB
Sponsored by
About this trial
This is an interventional prevention trial for Delayed Bleeding
Eligibility Criteria
Inclusion Criteria:
- the patients who agreed informed consent
- gastric adenoma or early gastric cancer which is eligible for conventional ESD indication
Exclusion Criteria:
- recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
- recent drug history of anticoagulant or antiplatelet agent within 7 days
- s/p subtotal gastrectomy
- recurred gastric adenoma or cancer
- pregnant or breast feeding patients
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high dose proton pump inhibitor
H2 receptor antagonist
Arm Description
Outcomes
Primary Outcome Measures
bleeding incidence after ESD
Secondary Outcome Measures
the size of healing ulcer after ESD
Full Information
NCT ID
NCT01179724
First Posted
August 10, 2010
Last Updated
August 10, 2010
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01179724
Brief Title
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
Official Title
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high dose proton pump inhibitor
Arm Type
Experimental
Arm Title
H2 receptor antagonist
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
high dose proton pump inhibitor
Other Intervention Name(s)
pantoprazole
Intervention Description
IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month
Intervention Type
Drug
Intervention Name(s)
H2RB
Other Intervention Name(s)
curan
Intervention Description
IV 50mg loading H2 receptor antagonist before 2hr to conduct ESD, and IV 13mg/h continuous infusion within 48hr, and then 300mg oral H2 receptor antagonist for one month
Primary Outcome Measure Information:
Title
bleeding incidence after ESD
Time Frame
time to occur delayed bleeding within one month after ESD
Secondary Outcome Measure Information:
Title
the size of healing ulcer after ESD
Time Frame
follow up endoscopy for the healing of iatrogenic ulcer after one month ESD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patients who agreed informed consent
gastric adenoma or early gastric cancer which is eligible for conventional ESD indication
Exclusion Criteria:
recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
recent drug history of anticoagulant or antiplatelet agent within 7 days
s/p subtotal gastrectomy
recurred gastric adenoma or cancer
pregnant or breast feeding patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae J Kim, professor
Phone
82-2-3410-3409
Email
jjkim@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
82
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae J Kim, Professor
Phone
82-2-3410-3409
Email
jjkim@skku.edu
First Name & Middle Initial & Last Name & Degree
Jae J Kim, Professor
12. IPD Sharing Statement
Learn more about this trial
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
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