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
  Purpose

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


Condition Intervention Phase
Gastric Tumor
Helicobacter Pylori
Endoscopic Resection
Metachronous Neoplasms
Drug: eradication treatment of Helicobacter pylori infection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 855
Study Start Date: January 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510730

Locations
Korea, Republic of
Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sang Gyun Kim, professor Department of Internal Medicine and Liver Research Institute
  More Information

No publications provided

Responsible Party: Jeongmin Choi, M.D., Seoul National University Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01510730     History of Changes
Other Study ID Numbers: 20052011
Study First Received: January 11, 2012
Last Updated: March 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
gastric tumor
Helicobacter pylori
endoscopic resection
metachronous neoplasms

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Neoplasms, Second Primary
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 20, 2014