H.Pylori Eradication RateNCT02921399
Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection for Gastric Neoplasm
An observational study of H.Pylori Eradication Rate, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- H.Pylori Eradication Rate
- What is being tested?
- eradication timing
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2016to 30 Jun 2021
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received proton-pump inhibitor (PPI)-based triple therapy for H. pylori eradication after endoscopic resection for gastric neoplasms. Clinicopathologic characteristics, particularly the timing of triple therapy, were used to compare eradication rates, assigning patients to early- (≤2 weeks),and late-phase (≥8 weeks) eradication groups.
Who may be able to join
- patients underwent endoscopic resection of gastric neoplasm
- patients who diagnosed as H. pylori infection by rapid urease test
Who cannot join
- Histories of gastric surgery
- Histories of prior H. pylori eradication therapy
- Use of drugs affecting H. pylori positivity (proton pump inhibitor, histamine-2 receptor blocker, or antibiotics) within the preceding 2 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Severance Hospital, Yonsei Unversity
Seoul, 06273
About this study
Official title: Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection
After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the investigators will conduct to evaluate whether differences in timing of eradication therapy after ER of gastric tumors.
Read the detailed description
Uur previous retrospective study unveiled that administering eradication treatment within 2 weeks post-ESD during the active reparative phase of ESD-induced ulcers yielded a markedly higher success rate compared to treatment post-8 weeks during the scarring phase of ESD-induced ulcers.Therefore, we conducted a multicenter, randomized, prospective study to ascertain whether the optimal timing of eradication post-ESD could influence the eradication success rate.
- Conditions
- H.Pylori Eradication Rate
- Being tested
- eradication timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eradication timingOther
patients who underwent ESD for gastric neoplasms were randomized to receive early (3-5 days) or late (8-9 weeks) H. pylori eradication therapy after ESD.
| Study group | Role | What they receive |
|---|---|---|
| early eradication group | In the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks). Receives: Other: eradication timing | |
| late eradication group | In the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks). Receives: Other: eradication timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection
The success of H. pylori eradication was determined using a urea breath test conducted
Measured: The success of H. pylori eradication was determined using a urea breath test conducted 13 weeks ± 5 days after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start10 Oct 2016
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H.Pylori Eradication RateStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoon Youn, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921399
- Sponsor's protocol ID
- 3-2016-0175
- Status last verified
- Apr 2024
- First submitted
- 29 Sep 2016
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh CW, Jung DH, Kim JH, Park H, Youn YH. Early versus Late Eradication of Helicobacter pylori after Endoscopic Submucosal Dissection of Gastric Neoplasms: A Prospective, Multicenter, Randomized, Controlled Study. Gut Liver. 2025 Nov 15;19(6):821-828. doi: 10.5009/gnl250004. Epub 2025 May 28.
PubMed 40425226
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection
- ClinicalTrials.gov ID
- NCT02921399
- Acronym / sponsor ID
- 3-2016-0175
- Conditions
- H.Pylori Eradication Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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.
After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the investigators will conduct to evaluate whether differences in timing of eradication therapy after ER of gastric tumors.
Detailed description
Uur previous retrospective study unveiled that administering eradication treatment within 2 weeks post-ESD during the active reparative phase of ESD-induced ulcers yielded a markedly higher success rate compared to treatment post-8 weeks during the scarring phase of ESD-induced ulcers.Therefore, we conducted a multicenter, randomized, prospective study to ascertain whether the optimal timing of eradication post-ESD could influence the eradication success rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early eradication group | – | Other: eradication timingIn the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks). |
| late eradication group | – | Other: eradication timingIn the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received proton-pump inhibitor (PPI)-based triple therapy for H. pylori eradication after endoscopic resection for gastric neoplasms. Clinicopathologic characteristics, particularly the timing of triple therapy, were used to compare eradication rates, assigning patients to early- (≤2 weeks),and late-phase (≥8 weeks) eradication groups.
Key inclusion criteria (2 listed)
- patients underwent endoscopic resection of gastric neoplasm
- patients who diagnosed as H. pylori infection by rapid urease test
Key exclusion criteria (3 listed)
- Histories of gastric surgery
- Histories of prior H. pylori eradication therapy
- Use of drugs affecting H. pylori positivity (proton pump inhibitor, histamine-2 receptor blocker, or antibiotics) within the preceding 2 weeks
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 |
|---|---|---|
| eradication timingpatients who underwent ESD for gastric neoplasms were randomized to receive early (3-5 days) or late (8-9 weeks) H. pylori eradication therapy after ESD. | Other | early eradication group, late eradication group |
Primary outcome
H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection
Time frame: The success of H. pylori eradication was determined using a urea breath test conducted 13 weeks ± 5 days after ESD
The success of H. pylori eradication was determined using a urea breath test conducted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 40425226Huh CW, Jung DH, Kim JH, Park H, Youn YH. Early versus Late Eradication of Helicobacter pylori after Endoscopic Submucosal Dissection of Gastric Neoplasms: A Prospective, Multicenter, Randomized, Controlled Study. Gut Liver. 2025 Nov 15;19(6):821-828. doi: 10.5009/gnl250004. Epub 2025 May 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 H.Pylori Eradication Rate, run by Gangnam Severance Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection (time frame: The success of H. pylori eradication was determined using a urea breath test conducted 13 weeks ± 5 days after ESD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921399, which also lists 1 linked publication.
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 12 Apr 2024.