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Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

NCT02407119 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2023-11-09

No results posted yet for this study

Summary

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Conditions

  • Helicobacter Pylori Infection
  • Early Gastric Cancer
  • Endoscopic Resection

Interventions

DRUG

7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin

Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Clarithromycin 500 mg bid for 7 days, Amoxicillin 1,000 mg bid for 7 days.

DRUG

Placebo, Omeprazole or Rabeprazole, Clarithromycin

Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Placebo for clarithromycin 500 mg bid for 7 days, Placebo for amoxicillin 1,000 mg bid for 7 days.

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Il Ju Choi, MD, PhD · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2016-06-30
Completion
2030-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02407119 on ClinicalTrials.gov