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Clinical Trials in South Korea / NCT02407119
Active, not recruiting Phase 3

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

NCT02407119 · tracked via the Priya Life Science South Korea tracker
Sponsor
National Cancer Center, Korea
Phase
Phase 3
Started
2003-06
Last updated
2023-11-09

Condition(s) studied

Helicobacter Pylori InfectionEarly Gastric CancerEndoscopic Resection

Investigational drug(s) / intervention(s)

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

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center, Korea Goyang-si Gyeonggi-do

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Other trials for the same condition

Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients Recruiting
Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients Recruiting
Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication Active, not recruiting
Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea Recruiting
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02407119 on ClinicalTrials.gov ↗ ← All trials in South Korea