Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
Condition: Gastric Polyp; Helicobacter Pylori Infection
MeSH terms: Stomach Neoplasms; Adenomatous Polyps; Polyps
Study type: Interventional
Phase: Phase 4

Summary: 
      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)
    

Detailed description: 
      (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.
    

Intervention name(s): H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
Intervention type(s): Drug
Intervention description(s): H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment
Other intervention name(s): Triple Therapy
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open labelled randomized controlled trial. randomization : 2015 September
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric polyp; Helicobacter pylori eradication