Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 6:42 AM
Study NCT ID:
NCT03065868
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2017-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp
Sponsor:
Kyungpook National University Hospital
Organization:
Study Overview
Official Title:
Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: