Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp

Study Overview
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Brief Summary
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Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial) 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 UBT (4week after eradication) Follow-up EGD: gross finding, CLO test Evaluation of polyp regression disappear regression over 50% (size, number) no change or increase (size, number)

Detailed Description
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(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 UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication) Follow-up EGD (3-9M): gross finding, CLO test Evaluation of polyp regression disappear regression over 50% (size, number) no change or increase (size, number) Statistical analysis Chi-square test to compare polyp regression between treatment & control group. t-test to compare continuous variables between treatment & control group. Paired T-test to compare the size between baseline and follow-up EGD. Regression analysis: univariate & multivariate analysis.

Official Title
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Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)

Conditions
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Gastric Polyp, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric polyp with current infection of H. pylori Gastric polyp size with 3mm-10mm Age of 20 yr - 70yr Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open labelled randomized controlled trial. randomization : 2015 September
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eradictaion<br>H. pylori eradication group | Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)<br>* H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment<br>* Other names: Triple Therapy;|
| No Intervention: non-eradication<br>H. pylori non-eradication group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp Study group H. pylori eradication H. pylori non-eradication Definition of gastric polyp change: Disappearance of gastric polyp Reduction of polyp size over 50% No change of size or increased size | up to 24months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric polyp, Helicobacter pylori eradication