Clinical trial · Interventional
Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
- 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)
Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial.The primary objective of this study is to evaluate whether Helicobacter pylori eradication improves glandular atrophy and intestinal metaplasia which are known to be precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Helicobacter pylori eradication | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- H. pylori eradication
- interventionNames
- Drug: Helicobacter pylori eradication
- type
- PLACEBO_COMPARATOR
- label
- placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Histological grading improvement rate
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * AGC or EGC confirmed by endoscopy * Histologically confirmed adenocarcinoma of stomach * Helicobacter pylori infection was confirmed by biopsy and CLO * Pre op CT stage: IA, IB, II, IIIA according to UICC TNM classification system * Pre op biopsy (body LC side) shows either intestinal metaplasia or glandular atrophy (at least grade 1) * Tumor location is suitable for subtotal gastrectomy- i.e. at or distal to lower body * Informed consent should be signed Exclusion Criteria: * Recurrent gastric cancer * Previous serious side effect to antibiotics * H. pylori eradication treatment history * 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)
- DERIVEDCho SJ, Choi IJ, Kook MC, Yoon H, Park S, Kim CG, Lee JY, Lee JH, Ryu KW, Kim YW. Randomised clinical trial: the effects of Helicobacter pylori eradication on glandular atrophy and intestinal metaplasia after subtotal gastrectomy for gastric cancer. Aliment Pharmacol Ther. 2013 Sep;38(5):477-89. doi: 10.1111/apt.12402. Epub 2013 Jul 3. PMID 23822578