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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Amoxicillin; Clarithromycin; Omeprazole; Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• Early Gastric cancer or high grade dysplasia confirmed by endoscopy

• Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia

• Submucosal invasion is not suspected

• No evidence of ulceration or ulcer scar within the lesion

• Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test

• Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system

• Informed consent should be signed

Exclusion Criteria:

• Recurrent gastric cancer

• Previous serious side effect to antibiotics

• H. pylori eradication treatment history

• Poorly differentiated adenocarcinoma or Signet ring cell carcinoma

• Undergoing operation due to complication of EMR

• Undergoing operation due to remnant cancer

• Other malignancy within the past 5 years

• Pregnant or nursing women

• Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases

• Psychiatric disorder that would preclude compliance