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

September 24, 2019 updated by: Su Youn Nam, Kyungpook National University Hospital

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Triple Therapy
No Intervention: non-eradication
H. pylori non-eradication group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Su Youn Y Nam, MD, PhD, Kyungpook National University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2015

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUMC_15-1045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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