Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
Primary Purpose
Gastric Polyp, Helicobacter Pylori Infection
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Polyp focused on measuring gastric polyp, Helicobacter pylori eradication
Eligibility 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.
Sites / Locations
- Su Youn Nam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
eradictaion
non-eradication
Arm Description
H. pylori eradication group
H. pylori non-eradication group
Outcomes
Primary Outcome Measures
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%
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03065868
First Posted
February 18, 2017
Last Updated
September 24, 2019
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03065868
Brief Title
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
Official Title
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 9, 2015 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial)
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)
Follow-up EGD: gross finding, CLO test
Evaluation of polyp regression
disappear
regression over 50% (size, number)
no change or increase (size, number)
Detailed Description
(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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Polyp, Helicobacter Pylori Infection
Keywords
gastric polyp, Helicobacter pylori eradication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
open labelled randomized controlled trial. randomization : 2015 September
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eradictaion
Arm Type
Experimental
Arm Description
H. pylori eradication group
Arm Title
non-eradication
Arm Type
No Intervention
Arm Description
H. pylori non-eradication group
Intervention Type
Drug
Intervention Name(s)
H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
Other Intervention Name(s)
Triple Therapy
Intervention Description
H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment
Primary Outcome Measure Information:
Title
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%
Description
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
Time Frame
up to 24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Youn Y Nam, MD, PhD
Organizational Affiliation
Kyungpook National University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Su Youn Nam
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31974914
Citation
Nam SY, Lee SW, Jeon SW, Kwon YH, Lee HS. Helicobacter pylori Eradication Regressed Gastric Hyperplastic Polyp: A Randomized Controlled Trial. Dig Dis Sci. 2020 Dec;65(12):3652-3659. doi: 10.1007/s10620-020-06065-0. Epub 2020 Jan 23.
Results Reference
derived
Learn more about this trial
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
We'll reach out to this number within 24 hrs