Effect of Helicobacter pylori eradication on remnant stomach neoplasm after curative gastrectomy
- Conditions
- Neoplasms
- Registration Number
- KCT0008855
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 984
(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
(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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The development of gastric neoplasms, including adenoma or adenocarcinoma in the remnant stomach of patients who received curative gastrectomy for gastric cancers
- Secondary Outcome Measures
Name Time Method 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