Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors
|Gastric Tumor Helicobacter Pylori Endoscopic Resection Metachronous Neoplasms||Drug: eradication treatment of Helicobacter pylori infection||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors|
- Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. [ Time Frame: we set the time frame as at least three years. ]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.
- effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor. [ Time Frame: 3 years ]Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement.
|Study Start Date:||January 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
No Intervention: control group
no treatment for Helicobacter pylori infection
Active Comparator: treatment group
treatment group receive eradication treatment for helicobacter pylori infection
Drug: eradication treatment of Helicobacter pylori infection
Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.
The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.
With respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.
Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.
So far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510730
|Korea, Republic of|
|Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Sang Gyun Kim, professor||Department of Internal Medicine and Liver Research Institute|