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

Korean College of Helicobacter and Upper Gastrointestinal Research

Status and phase: Unknown; Phase 4

Conditions: Ulcer

Treatments: Drug: Lansoprazole (proton pump inhibitor), placebo; Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00926809

2009KHR001

Details and patient eligibility

About

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.

Enrollment: 232 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

232 participants in 2 patient groups, including a placebo group

Eradication

Active Comparator group

Description:

Helicobacter pylori eradication

Treatment:

Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

No eradication

Placebo Comparator group

Description:

No eradication for Helicobacter pylori

Treatment:

Drug: Lansoprazole (proton pump inhibitor), placebo