Helicobacter Pylori Infection Clinical Trial
Official title:
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)
Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric
polyp (Ranomized controlled trial)
1. Study design: open labeled RCT
2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
3. Treatment plan
1. 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
1. disappear
2. regression over 50% (size, number)
3. no change or increase (size, number)
(A) Study population
1. inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr
2. 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
1. Study design: open labeled RCT
2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
3. Treatment plan
1. 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) if eradication failure in triple therapy, 2nd line
treatment (metroniazole based quadraple therpay) and the UBT (4week after
eradication)
4. Follow-up EGD (3-9M): gross finding, CLO test
4. Evaluation of polyp regression
1. disappear
2. regression over 50% (size, number)
3. no change or increase (size, number)
5. Statistical analysis
1. Chi-square test to compare polyp regression between treatment & control group.
2. t-test to compare continuous variables between treatment & control group.
3. Paired T-test to compare the size between baseline and follow-up EGD.
4. Regression analysis: univariate & multivariate analysis.
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