NCT01510730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
855

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

6.1 years

First QC Date

January 11, 2012

Last Update Submit

March 13, 2012

Conditions

Gastric TumorHelicobacter PyloriEndoscopic ResectionMetachronous Neoplasms

Keywords

gastric tumorHelicobacter pyloriendoscopic resectionmetachronous neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    we set the time frame as at least three years.

Secondary Outcomes (1)

  • effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor.

    3 years

Study Arms (2)

control group

NO INTERVENTION

no treatment for Helicobacter pylori infection

treatment group

ACTIVE COMPARATOR

treatment group receive eradication treatment for helicobacter pylori infection

Drug: eradication treatment of Helicobacter pylori infection

Interventions

eradication treatment of Helicobacter pylori infectionDRUG

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

treatment group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer
  • Gastric tumor is completely removed through endoscopic resection.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 29800546DERIVED

  • 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.

    PMID: 24100112DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasms, Second Primary

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Sang Gyun Kim, professor

    Department of Internal Medicine and Liver Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Seoul National University Hospital

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 16, 2012

Study Start

January 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

KR(1)