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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065868
• Other study ID #: KNUMC_15-1045
• Status: Completed
• Phase: Phase 4
• Start date: December 9, 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2019
• Source: Kyungpook National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomatous Polyps
• Gastric Polyp
• Helicobacter Pylori Infection
• Polyps
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Su Youn Nam	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp; Study group; H. pylori eradication; H. pylori non-eradication; Definition of gastric polyp change: Disappearance of gastric polyp; Reduction of polyp size over 50%; No change of size or increased size	up to 24months