Community-based Helicobacter Pylori Eradication
1 other identifier
interventional
5,000
1 country
2
Brief Summary
Based on a universal eradication of H. pylori in an offshore island (Matsu) with a high prevalence of gastric cancer as well as premalignant gastric lesion, we first examined the infection rate of H. pylori. Secondly, we evaluated the efficacy of clarithromycin-based triple therapy with a levofloxacin-based rescue treatment. And thirdly, we tested the hypothesis that whether the cure of H. pylori can reverse the premalignant gastric lesion. Fourth, we determine the cost-effectiveness of this intervention. The gene-environment interaction will be addressed regarding gastric cancer carcinogenesis. Finally, the incident rate of gastric cancer would be followed in this cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2004
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 14, 2012
July 1, 2012
11.9 years
September 8, 2005
November 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate
12 years
Secondary Outcomes (1)
Intragastric histologic change
12 years
Study Arms (1)
H pylori eradication
ACTIVE COMPARATORAll enrolled subjects received chemoprevention with Helicobacter pylori eradication
Interventions
For subjects who received the first-line treatment, the costs included the initial 13C-UBT, one-week triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and clarithromycin 500mg twice daily), and the confirmatory 13C-UBT. For subjects in whom the initial treatment failed, the costs further included the re-treatment consisting of ten-day triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and levofloxacin 500mg once daily), and the confirmatory 13C-UBT. The first round of study was between 2004 and 2005, the second round was between 2008 and 2009, and the third round was between 2012 and 2013.
Eligibility Criteria
You may qualify if:
- Helicobacter pylori infection subjects
You may not qualify if:
- Prior gastrectomy; pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lee Yi-Chia
Taipei, 10015, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (6)
Lee YC, Lin JT, Wu HM, Liu TY, Yen MF, Chiu HM, Wang HP, Wu MS, Hsiu-Hsi Chen T. Cost-effectiveness analysis between primary and secondary preventive strategies for gastric cancer. Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):875-85. doi: 10.1158/1055-9965.EPI-06-0758.
PMID: 17507609BACKGROUNDLiu CY, Wu CY, Lin JT, Lee YC, Yen AM, Chen TH. Multistate and multifactorial progression of gastric cancer: results from community-based mass screening for gastric cancer. J Med Screen. 2006;13 Suppl 1:S2-5.
PMID: 17227633BACKGROUNDLee YC, Lin JT, Chen TH, Wu MS. Is eradication of Helicobacter pylori the feasible way to prevent gastric cancer? New evidence and progress, but still a long way to go. J Formos Med Assoc. 2008 Aug;107(8):591-9. doi: 10.1016/S0929-6646(08)60176-X.
PMID: 18678542BACKGROUNDLee YC, Wu HM, Chen TH, Liu TY, Chiu HM, Chang CC, Wang HP, Wu MS, Chiang H, Wu MC, Lin JT. A community-based study of Helicobacter pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. Helicobacter. 2006 Oct;11(5):418-24. doi: 10.1111/j.1523-5378.2006.00432.x.
PMID: 16961802RESULTChiang TH, Chang WJ, Chen SL, Yen AM, Fann JC, Chiu SY, Chen YR, Chuang SL, Shieh CF, Liu CY, Chiu HM, Chiang H, Shun CT, Lin MW, Wu MS, Lin JT, Chan CC, Graham DY, Chen HH, Lee YC. Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands. Gut. 2021 Feb;70(2):243-250. doi: 10.1136/gutjnl-2020-322200. Epub 2020 Aug 13.
PMID: 32792335DERIVEDLee YC, Chen TH, Chiu HM, Shun CT, Chiang H, Liu TY, Wu MS, Lin JT. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut. 2013 May;62(5):676-82. doi: 10.1136/gutjnl-2012-302240. Epub 2012 Jun 14.
PMID: 22698649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pan-Chyr Yang, PHD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2004
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 14, 2012
Record last verified: 2012-07