Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Compare regression rate of gastric polyps between H. pylori eradication and non-eradication groups. Regression of gastric polyp: one of below 1) Disappearance of gastric polyp 2) Reduction of polyp size over 50%
研究概览
简要总结
Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial)
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Study design: open labeled RCT
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Study group H. pylori eradication group (N=17), non-eradication group (N=15)
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Treatment plan
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Baseline EGD
: 0.3-1cm sized polyp - bx & CLO test (antrum & body)
==> if H. pylori positive and eligible patients, randomization 2. Triple therapy 3. UBT (4week after eradication) 4. Follow-up EGD: gross finding, CLO test 4. Evaluation of polyp regression
- disappear
- regression over 50% (size, number)
- no change or increase (size, number)
详细描述
(A) Study population
- inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr
- exclusion peptic ulcer, healing stage or acute stage recent use of PPI within 4weeks Liver cirrhosis, renal insufficiency, other serious chronic or acute disease current infection of other bacteria, virus, or fungus cancer, psychologic disease heavy drinker drug abuser pregnant women, Penicillin allergy, digoxin, antifungal, wafarin previosu H. pylori eradication enroll gastric polyp with bleeding or malignant transformation tiny polyp less than 3mm.
(B) Study method
-
Study design: open labeled RCT
-
Study group H. pylori eradication group (N=17), non-eradication group (N=15)
-
Treatment plan
-
Baseline EGD: 0.3-1cm sized polyp - bx & CLO test (antrum & body) ==> if H. pylori positive and eligible patients, randomization
-
Triple therapy
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UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication)
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Follow-up EGD (3-9M): gross finding, CLO test
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Evaluation of polyp regression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric polyp with current infection of H. pylori
- •Gastric polyp size with 3mm-10mm
- •Age of 20 yr - 70yr
排除标准
- •Gastric ulcer ir duodenal ulcer (healing stage or acute stage)
- •Use of PPI within 4weeks
- •Liver cirrhosis, renal insufficiency, other serious chronic or acute disease
- •Current infection of other bacteria, virus, or fungus
- •Any cancer, psychologic disease
- •Heavy drinker
- •Drug abuser
- •Pregnant women
- •Penicillin allergy
- •Use of digoxin, antifungal, wafarin
- •Previous H. pylori eradication
- •Gastric polyp with bleeding or malignant transformation
- •Tiny polyp less than 3mm.
研究组 & 干预措施
eradictaion
H. pylori eradication group
干预措施: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin) (Drug)
结局指标
主要结局
Compare regression rate of gastric polyps between H. pylori eradication and non-eradication groups. Regression of gastric polyp: one of below 1) Disappearance of gastric polyp 2) Reduction of polyp size over 50%
时间窗: up to 24months
Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp Study group 1. H. pylori eradication 2. H. pylori non-eradication Definition of gastric polyp change: 1. Disappearance of gastric polyp 2. Reduction of polyp size over 50% 3. No change of size or increased size
次要结局
未报告次要终点
研究者
Su Youn Nam
Clinical professor
Kyungpook National University Chilgok Hospital