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Effect of Helicobacter pylori eradication on remnant stomach neoplasm after curative gastrectomy

Effect of Helicobacter pylori eradication on remnant stomach neoplasm after curative gastrectomy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0008855
Enrollment
984
Registered
2023-10-10
Start date
2024-06-27
Completion date
Unknown
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1)Group A (Treatment arm) Patients in the eradication arm receive the standard regimen consisting of proton pump inhibitor (esomeprazole 40 mg), amoxicillin 1 g, and clarithromycin 500 mg twice

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) aged 19–70 years (2) who are diagnosed with H. pylori infection (3) who are diagnosed with pathologic stage 1 gastric cancer (4) who received distal gastrectomy for cancer located in the lower half of the stomach (pylorus, antrum, and lower body), and who received proximal gastrectomy for cancer located in the upper half of the stomach (fundus, cardia, upper body, and mid body) either requiring upfront curative gastrectomy or additional surgery after non-curative endoscopic resection (5) not indicated to adjuvant chemotherapy

Exclusion criteria

Exclusion criteria: (1) history of HPE (2) history of previous gastrectomy (3) history of any malignancy within recent 10 years (4) Patient who previously undergone endoscopic treatment on the section that will become the remnant stomach (5) patients who require neoadjuvant chemotherapy (6) history of allergy or serious adverse events to prescribed medication including amoxicillin and clarithromycin (7) presence of severe comorbidity (e.g. cardiac, hepatic, or renal insufficiency) or coagulopathy (8) pregnant or lactating women (9) presence of psychiatric disorder that may preclude compliance (10) patients who cannot understand informed consent. (11) Borrmann type 4 tumors (linitis plastica) on tumor classification (12) Proximal resection margin shorter than 3cm in cases of advanced gastric cancer (13) Declined to participate (14) Withdrew consent

Design outcomes

Primary

MeasureTime frame
The development of gastric neoplasms, including adenoma or adenocarcinoma in the remnant stomach of patients who received curative gastrectomy for gastric cancers

Secondary

MeasureTime frame
1) the 10-year overall survival, 2) the improvement rates of the gastric glandular atrophy and/or intestinal metaplasia, 3) HP eradication success rate, and 4) the incidence of new-onset hyperplastic polyps

Countries

Korea, Republic of

Contacts

Public ContactChang Seok Ko

Asan Medical Center

kochs815@naver.com+82-2-3010-0550

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026