H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection

Korean College of Helicobacter and Upper Gastrointestinal Research232 enrolled

Overview

This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

232

Conditions

Ulcer

Interventions

Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycinDRUG

Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg

Lansoprazole (proton pump inhibitor), placeboDRUG

Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 30 - 75 years old * Early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size) * Helicobacter pylori positive Exclusion Criteria: * Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound) * History of Helicobacter pylori eradication * History of gastric surgery or other cancers * Major comorbidities * Medication of ASA, NSAIDS, steroids, anti-coagulants

Locations (6)

National Cancer Center Korea

Goyang, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Korea University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

ulcer healing rate by endoscopic assessment

Time frame: 8 weeks

Secondary Outcomes

ulcer reduction rate by endoscopic assessment

Time frame: 8 weeks

Central Contacts

Ho June Song, Ph.D

CONTACT

82-2-3010-3916 hojunesong@yahoo.co.kr

Data from ClinicalTrials.gov

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