NCT03065868

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Polyp
• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-09
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2017-02-28
• Last updated: 2019-09-26

Locations

1 site across 1 country: South Korea