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

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Gastric Polyp; Helicobacter Pylori Infection

Treatments: Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

Study type: Interventional

Funder types: Other

Identifiers

NCT03065868

KNUMC_15-1045

Details and patient eligibility

About

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)

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

eradictaion

Experimental group

Description:

H. pylori eradication group

Treatment:

Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

non-eradication

No Intervention group

Description:

H. pylori non-eradication group