Loading clinical trials...
Loading clinical trials...
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)
(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.
Age
20 - 70 years
Sex
ALL
Healthy Volunteers
No
Su Youn Nam
Daegu, South Korea
Start Date
December 9, 2015
Primary Completion Date
April 30, 2019
Completion Date
April 30, 2019
Last Updated
September 26, 2019
32
ACTUAL participants
H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
DRUG
Lead Sponsor
Kyungpook National University Hospital
NCT07179159
NCT07293910
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04191551