Delayed Bleeding
Conditions
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
Interventions
DRUGhigh dose proton pump inhibitor
IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month
DRUGH2RB
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
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bleeding incidence after ESD | time to occur delayed bleeding within one month after ESD |
Secondary
| Measure | Time frame |
|---|---|
| the size of healing ulcer after ESD | follow up endoscopy for the healing of iatrogenic ulcer after one month ESD |
Countries
South Korea
Contacts
Primary ContactJae J Kim, professor
Outcome results
None listed