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Completed

NCT Number: NCT01510730

Helicobacter Pylori Eradication 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.

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Key information

Conditions

Gastric Tumor Digestive System Diseases Digestive System Neoplasms Endoscopic Resection Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Metachronous Neoplasms Neoplasms Neoplasms by Site Neoplasms, Second Primary Stomach Diseases Stomach Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eradication treatment of Helicobacter pylori infection

Drug

Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2012
Registry last updated
Mar 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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