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Completed

NCT Number: NCT03065868

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

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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Key information

Conditions

Gastric Polyp Helicobacter Pylori Infection Polyposis, Gastric

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Su Youn Nam

Daegu, 41404, South Korea

About this study

(A) Study population

  • inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr
  • 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

  • Study design: open labeled RCT
  • Study group H. pylori eradication group (N=17), non-eradication group (N=15)
  • Treatment plan
  • Baseline EGD: 0.3-1cm sized polyp - bx & CLO test (antrum & body) ==> if H. pylori positive and eligible patients, randomization
  • Triple therapy
  • UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication)
  • Follow-up EGD (3-9M): gross finding, CLO test
  • Evaluation of polyp regression
  • disappear
  • regression over 50% (size, number)
  • no change or increase (size, number)
  • Statistical analysis
  • Chi-square test to compare polyp regression between treatment & control group.
  • t-test to compare continuous variables between treatment & control group.
  • Paired T-test to compare the size between baseline and follow-up EGD.
  • Regression analysis: univariate & multivariate analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

Drug

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

Other names: Triple Therapy

Primary outcomes

  1. 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%

    Time frame: up to 24months

    Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp

    Study group

    • H. pylori eradication
    • H. pylori non-eradication

    Definition of gastric polyp change:

    • Disappearance of gastric polyp
    • Reduction of polyp size over 50%
    • No change of size or increased size

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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