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

Delayed Bleeding Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01179724
• Other study ID #: 2009-06-030
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2010
• Last updated: August 10, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2009
• Source: Samsung Medical Center
• Contact: Jae J Kim, professor
• Phone: 82-2-3410-3409
• Email: jjkim[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delayed Bleeding
• Hemorrhage
• Stomach Neoplasms

Intervention

Drug:
• high 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
• H2RB
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding incidence after ESD		time to occur delayed bleeding within one month after ESD	No
Secondary	the size of healing ulcer after ESD		follow up endoscopy for the healing of iatrogenic ulcer after one month ESD	No