Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer

NCT02407119 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	National Cancer Center, Korea
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	470
Start date	2003-06
Completion	2030-06

Conditions

• Helicobacter Pylori Infection
• Early Gastric Cancer
• Endoscopic Resection

Interventions

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

Primary outcomes

• Improvement (histological) of glandular atrophy — 3 years after enrollment
  Improvement of glandular atrophy at the corpus lesser curvature
• Incidence of metachronous gastric cancer — 3 years after last patient enrollment
  Comparison of metachronous gastric cancer according to the allocated treatment

Countries

South Korea