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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-09

Study Completion Date

2019-04-30

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)

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)

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Detailed Description

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(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.

Conditions

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Gastric Polyp Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open labelled randomized controlled trial. randomization : 2015 September

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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eradictaion

H. pylori eradication group

Group Type EXPERIMENTAL

H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

Intervention Type DRUG

H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment

non-eradication

H. pylori non-eradication group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment

Intervention Type DRUG

Other Intervention Names

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Triple Therapy

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No