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

Phase 4

Completed

• Conditions: Gastric Polyp; Helicobacter Pylori Infection
• Interventions: Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

• Registration Number: NCT03065868
• Lead Sponsor: Kyungpook National University Hospital

Brief 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.

Study Timeline

• Study Start: 2015-12-09
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eradictaion	H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)	H. pylori eradication group

Primary Outcome Measures

Name	Time	Method
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%	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

Trial Locations

Locations (1)

Su Youn Nam; 🇰🇷 Daegu, Korea, Republic of