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

K

Kyungpook National University

Status and phase

Completed
Phase 4

Conditions

Gastric Polyp
Helicobacter Pylori Infection

Treatments

Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

Study type

Interventional

Funder types

Other

Identifiers

NCT03065868
KNUMC_15-1045

Details and patient eligibility

About

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)

Full 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.

Enrollment

32 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

eradictaion
Experimental group
Description:
H. pylori eradication group
Treatment:
Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
non-eradication
No Intervention group
Description:
H. pylori non-eradication group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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