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

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01179724

Collaborator

(none)

206

Enrollment

Location

Arms

Duration (Months)

14.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Delayed Bleeding	Drug: high dose proton pump inhibitor Drug: H2RB	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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 Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high dose proton pump inhibitor	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 Other Names: pantoprazole
Active Comparator: H2 receptor antagonist	Drug: 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 Other Names: curan

Arm

Intervention/Treatment

Experimental: high dose proton pump inhibitor

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

Other Names:

pantoprazole

Active Comparator: H2 receptor antagonist

Drug: 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

Other Names:

curan

Outcome Measures

Primary Outcome Measures

bleeding incidence after ESD [time to occur delayed bleeding within one month after ESD]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	82

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01179724

Other Study ID Numbers:

2009-06-030

First Posted:

Aug 11, 2010

Last Update Posted:

Aug 11, 2010

Last Verified:

Jun 1, 2009

Additional relevant MeSH terms:

Proton Pump Inhibitors

Study Results

No Results Posted as of Aug 11, 2010