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

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ClinicalTrials.gov Identifier: NCT03065868
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Su Youn Nam, Kyungpook National University Chilgok 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)

Condition or disease Intervention/treatment Phase
Gastric Polyp Helicobacter Pylori Infection Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open labelled randomized controlled trial. randomization : 2015 September
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eradictaion
H. pylori eradication group
Drug: 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
Other Name: Triple Therapy

No Intervention: non-eradication
H. pylori non-eradication group



Primary Outcome Measures :
  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

    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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065868


Locations
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Korea, Republic of
Su Youn Nam
Daegu, Korea, Republic of, 41404
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Su Youn Y Nam, MD, PhD Kyungpook National University Medical Center

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Responsible Party: Su Youn Nam, Clinical professor, Kyungpook National University Chilgok Hospital
ClinicalTrials.gov Identifier: NCT03065868     History of Changes
Other Study ID Numbers: KNUMC_15-1045
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Su Youn Nam, Kyungpook National University Chilgok Hospital:
gastric polyp
Helicobacter pylori eradication
Additional relevant MeSH terms:
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Stomach Neoplasms
Adenomatous Polyps
Polyps
Pathological Conditions, Anatomical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors