No intervention in Lymphoma and Gastritis and Gastric Cancer - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Other: No intervention

Detailed Description

Backgrounds:

The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.

Theories and Plans:

The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Study Type

Observational

Enrollment (Anticipated)

400

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
- - Seoul, Korea, Republic of, 05505
    - Department of Gastroenterology, University of Ulsan College of Medicine, 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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The subjects required to the examination of Helicobacter pylori infection is necessary during upper gastrointestinal endoscopy due to peptic ulcer, lymphoma, gastric cancer, gastritis, et al.

Description

Inclusion Criteria:

Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
No history of Helicobacter pylori eradication.
No history of antibiotics within one month.
Person who agree on the consent.

Exclusion Criteria:

History of antibiotics more than 3 days sequentially within one month.
History of subtotal gastrectomy.
Person who does not agree on the consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method) Time Frame: 6 more days	The resistance criterion specifies that Clarithromycin is excess of 1.0 μg/mL, Amoxicillin is excess of 0.5 μg/mL, Metronidazole is excess of 8 μg/mL, Tetracycline is excess of 4 μg/mL, Levofloxacin is excess of 1 μg/mL and Ciprofloxacin is excess of 1 μg/mL. All of resistance criteria follow a criteria of NCCLS(National Committee for Clinical Laboratory Standards)	6 more days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The gap of the rate of the antibiotic resistance to H. pylori by regional groups Time Frame: 6 more days		6 more days
The success rate of H. pylori strain separation Time Frame: 6 more days	Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.	6 more days

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

National Evidence-Based Healthcare Collaborating Agency

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

October 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Estimate)