Clinical trial · Interventional
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
NCT02407119CI-TRIAL-00071205active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Endoscopic Resection | — | UNRESOLVED | — |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin | Drug | — | UNRESOLVED |
| Placebo, Omeprazole or Rabeprazole, Clarithromycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 7 day H.pylori eradication
- description
- Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
- interventionNames
- Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days
- interventionNames
- Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin
Primary outcomes (2)
- measure
- Improvement (histological) of glandular atrophy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChoi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423. PMID 29562147