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

NCT01179724 | Unknown

• 1 other identifier: 2009-06-030
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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

Conditions

Delayed Bleeding

Outcome Measures

Primary Outcomes (1)

• bleeding incidence after ESD

  time to occur delayed bleeding within one month after ESD

Secondary Outcomes (1)

• the size of healing ulcer after ESD

  follow up endoscopy for the healing of iatrogenic ulcer after one month ESD

Study Arms (2)

high dose proton pump inhibitor

EXPERIMENTAL

Drug: high dose proton pump inhibitor

H2 receptor antagonist

ACTIVE COMPARATOR

Drug: H2RB

Interventions

high dose proton pump inhibitor DRUG

IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month

Also known as: pantoprazole

high dose proton pump inhibitor

H2RB DRUG

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

Also known as: curan

H2 receptor antagonist

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patients who agreed informed consent
• gastric adenoma or early gastric cancer which is eligible for conventional ESD indication

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 82, South Korea

RECRUITING

MeSH Terms

Interventions

Proton Pump Inhibitors; Pantoprazole

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Jae J Kim, professor

CONTACT

82-2-3410-3409; jjkim@skku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2009-06

Locations

KR (1)