Helicobacter Pylori Clinical Trial
Official title:
Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors
Verified date | March 2012 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.
Status | Completed |
Enrollment | 855 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer - Gastric tumor is completely removed through endoscopic resection. Exclusion Criteria: - Patients underwent gastrectomy before enrollment - patients underwent endoscopic resection before enrollment - Previous history of eradication for H. pylori - Pregnancy - Aged <20 yr old or aged >75 yr old - Patients underwent additional gastrectomy due to incomplete endoscopic resection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. | Primary outcome is the incidence of new cancer development after endoscopic resection of gastric tumors between eradication and control groups. Previous reports showed the incidence of new cancer between two groups differs at least 3years. | we set the time frame as at least three years. | No |
Secondary | effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor. | Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement. | 3 years | No |
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