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Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeongmin Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01510730
First received: January 11, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes

January 11, 2012
March 13, 2012
January 2005
February 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01510730 on ClinicalTrials.gov Archive Site
effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement.
effect of eradication of Helicobacter pylori on incidence of new cancer and high grade dysplasia development after endoscopic resection of gastric tumor. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Gastric high grade dysplasia has high malignant potential. Considering this, if we assume that high grade dysplasia can be incorporated into the carcinoma, we include high grade dysplasia and gastric carcinoma as secondary outcome measurement.
Not Provided
Not Provided
 
Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors
Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Tumor
  • Helicobacter Pylori
  • Endoscopic Resection
  • Metachronous Neoplasms
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.
  • No Intervention: control group
    no treatment for Helicobacter pylori infection
  • Active Comparator: treatment group
    treatment group receive eradication treatment for helicobacter pylori infection
    Intervention: Drug: eradication treatment of Helicobacter pylori infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01510730
20052011
No
Jeongmin Choi, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Sang Gyun Kim, professor Department of Internal Medicine and Liver Research Institute
Seoul National University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP