Helicobacter Pylori InfectionsNCT03419936
Distribution of Helicobacter Pylori After Gastrectomy
An observational study of Helicobacter Pylori Infections, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infections
- What is being tested?
- Endoscopic biopsy
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2016to 21 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample size will be determined based on the analysis the distribution rate of Helicobacter pylori at first 60 patients.
Who may be able to join
- Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
- Aged between 19 to 75 years
- Informed consent
Who cannot join
- Previous history of Helicobacter pylori eradication
- Previous history of proton pump inhibitor use within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 138-736
myungeun lee, BA, +82-2-3010-7190, lme23@amc.seoul.kr
Ji Yong Ahn, Professor
About this study
Official title: 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.
Read the detailed description
Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.
- Conditions
- Helicobacter Pylori Infections
- Being tested
- Endoscopic biopsy
- Keywords
- Stomach Neoplasms, Helicobacter pylori, Subtotal gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biopsyDiagnostic test
- Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
- Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
- Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
- Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pylori(HP) positive | Participants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy. Receives: Diagnostic Test: Endoscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Helicobacter Pylori After Gastrectomy
Analysis the change of Helicobacter pylori according to the subtotal gastrectomy
Measured: Change in the distribution of Helicobacter Pylori at 2 years
Secondary outcomes (1)
Change of atrophy after gastrectomy
Analysis the change of atrophic status according to the subtotal gastrectomy
Measured: Change in the atrophic status at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start21 Mar 2016
- Primary completion21 Mar 2020 (estimated)
- Study completion21 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yong Ahn, Asan Medical Center
- Investigators
- Ji Yong Ahn, Professor, Principal investigator, Study Principal Investigator Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419936
- Sponsor's protocol ID
- 2015-0823
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy
- ClinicalTrials.gov ID
- NCT03419936
- Acronym / sponsor ID
- 2015-0823
- Conditions
- Helicobacter Pylori Infections
- Keywords
- Stomach Neoplasms, Helicobacter pylori, Subtotal gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 21 Mar 2020 (estimated)
- Study completion
- 21 Mar 2020 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.
Detailed description
Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori(HP) positive | – | Diagnostic Test: Endoscopic biopsyParticipants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size will be determined based on the analysis the distribution rate of Helicobacter pylori at first 60 patients.
Key inclusion criteria (3 listed)
- Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
- Aged between 19 to 75 years
- Informed consent
Key exclusion criteria (2 listed)
- Previous history of Helicobacter pylori eradication
- Previous history of proton pump inhibitor use within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic biopsy1. 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. | Diagnostic test | Helicobacter pylori(HP) positive |
Primary outcome
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
1 secondary outcome
Change of atrophy after gastrectomy
Time frame: Change in the atrophic status at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Yong Ahn, Professor principal investigator
Study Principal Investigator Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infections, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact myungeun Lee, BA (+82-2-3010-7190, lme23@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Helicobacter Pylori After Gastrectomy (time frame: Change in the distribution of Helicobacter Pylori at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.