Distribution of Helicobacter Pylori After Gastrectomy

January 27, 2018 updated by: Ji Yong Ahn, Asan Medical Center

Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy

The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sample size will be determined based on the analysis the distribution rate of Helicobacter pylori at first 60 patients.

Description

Inclusion Criteria:

  1. Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
  2. Aged between 19 to 75 years
  3. Informed consent

Exclusion Criteria:

  1. Previous history of Helicobacter pylori eradication
  2. Previous history of proton pump inhibitor use within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Helicobacter pylori(HP) positive
Participants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy.
Diagnostic test: Endoscopic biopsy
  1. Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
  2. Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
  3. Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
  4. Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Helicobacter Pylori After Gastrectomy
Time Frame: Change in the distribution of Helicobacter Pylori at 2 years
Analysis the change of Helicobacter pylori according to the subtotal gastrectomy
Change in the distribution of Helicobacter Pylori at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of atrophy after gastrectomy
Time Frame: Change in the atrophic status at 2 years
Analysis the change of atrophic status according to the subtotal gastrectomy
Change in the atrophic status at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Ji Yong Ahn, Professor, Study Principal Investigator Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2016

Primary Completion (ANTICIPATED)

March 21, 2020

Study Completion (ANTICIPATED)

March 21, 2020

Study Registration Dates

First Submitted

January 27, 2018

First Submitted That Met QC Criteria

January 27, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-0823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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