Clinical trial NCT03065868: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Polyp
Helicobacter Pylori Infection
Keywords: gastric polyp
Helicobacter pylori eradication
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open labelled randomized controlled trial. randomization : 2015 September
Primary purpose: TREATMENT

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)

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.

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.

Primary outcomes:
measure: 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%
timeFrame: up to 24months
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Su Youn Nam
Study officials:
affiliation: Kyungpook National University Medical Center
name: Su Youn Y Nam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.