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Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

Primary Purpose

Gastric Tumor, Helicobacter Pylori, Endoscopic Resection

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
eradication treatment of Helicobacter pylori infection
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Tumor focused on measuring gastric tumor, Helicobacter pylori, endoscopic resection, metachronous neoplasms

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

treatment group

Arm Description

no treatment for Helicobacter pylori infection

treatment group receive eradication treatment for helicobacter pylori infection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 11, 2012
Last Updated
March 13, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01510730
Brief Title
Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors
Official Title
Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Tumor, Helicobacter Pylori, Endoscopic Resection, Metachronous Neoplasms
Keywords
gastric tumor, Helicobacter pylori, endoscopic resection, metachronous neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
855 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
no treatment for Helicobacter pylori infection
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
treatment group receive eradication treatment for helicobacter pylori infection
Intervention Type
Drug
Intervention Name(s)
eradication treatment of Helicobacter pylori infection
Intervention Description
Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.
Primary Outcome Measure Information:
Title
Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor.
Description
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.
Time Frame
we set the time frame as at least three years.
Secondary Outcome Measure Information:
Title
effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor.
Description
Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Gyun Kim, professor
Organizational Affiliation
Department of Internal Medicine and Liver Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29800546
Citation
Choi JM, Kim SG, Choi J, Park JY, Oh S, Yang HJ, Lim JH, Im JP, Kim JS, Jung HC. Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention: a randomized controlled trial. Gastrointest Endosc. 2018 Sep;88(3):475-485.e2. doi: 10.1016/j.gie.2018.05.009. Epub 2018 May 22.
Results Reference
derived
PubMed Identifier
24100112
Citation
Choi J, Kim SG, Yoon H, Im JP, Kim JS, Kim WH, Jung HC. Eradication of Helicobacter pylori after endoscopic resection of gastric tumors does not reduce incidence of metachronous gastric carcinoma. Clin Gastroenterol Hepatol. 2014 May;12(5):793-800.e1. doi: 10.1016/j.cgh.2013.09.057. Epub 2013 Oct 5.
Results Reference
derived

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Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

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