Know Cancer

forgot password

Community-based Helicobacter Pylori Eradication With Two Sequential Antibiotic Regimens for the Residents and Migrants From a High-risk Area for Gastric Cancer

Phase 4
30 Years
Open (Enrolling)
Helicobacter Pylori Infection

Thank you

Trial Information

Community-based Helicobacter Pylori Eradication With Two Sequential Antibiotic Regimens for the Residents and Migrants From a High-risk Area for Gastric Cancer

Despite the decline of global incidence, gastric cancer still affects public health
substantially due to the considerable medical burden in the treatment of disease at the
symptomatic stage. This fact has prompted clinicians to extend their attention from the
multidisciplinary therapies to the design of preventive strategies. Gastric cancer
development follows a carcinogenic process from non-atrophic gastritis, atrophic gastritis,
intestinal metaplasia, dysplasia, and eventually to the adenocarcinoma. Helicobacter pylori
(H. pylori) infection triggers this carcinogenic cascade and its eradication is currently
the most reliable regimen to arrest the histologic progression in order to prevent gastric
cancer. Emerging data have suggested that the benefit of H. pylori treatment earlier in the
course of infection is larger and cannot be outweighed by a disfavored discount rate as a
result of different time horizons between early treatment and later benefit of averting
advanced cancer.

In the Asia-Pacific area, however, virulent strains of H. pylori infection are highly
prevalent and premalignant gastric lesions may have already developed at the take-off age of
active intervention. Our current knowledge remains limited in answering whether H. pylori
eradication can regress these premalignant lesions and if so, what determinant can
contribute to a positive response is unknown. The concept of "a point of no return" suggests
that the benefit of H. pylori eradication may diminish at later stages when many types of
molecular damage become irreversible. Several population-based studies, in contrast, found
that the premalignant gastric lesions were potentially reversible given a sufficiently long
duration free from infection. The inconsistence may reflect the facts that studies with
adequate sample size and long enough follow-up are rarely available and that some important
factors, such as the variation in host susceptibility to disease and dietary exposure to
carcinogens, are difficult to be measured but they are likely to confound the results.

Therefore, the present study was to:

1. Determine the efficacy of a novel regimen to treat the H. pylori infection in the
general population.

2. To address the question whether the premalignant gastric lesion could be reversed
following the cure of infection.

3. To simulate the cost-effectiveness of this chemoprevention.

4. To use individual data to empirically calculate the cost-effectiveness of this

5. To address the host genetic susceptibility to gastric cancer development.

6. To follow-up the gastric cancer incidence following the eradication of H. pylori.

Inclusion Criteria:

- Helicobacter pylori infection subjects

Exclusion Criteria:

- Prior gastrectomy; pregnant women

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate

Outcome Time Frame:

12 years

Safety Issue:


Principal Investigator

Pan-Chyr Yang, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2004

Completion Date:

December 2015

Related Keywords:

  • Helicobacter Pylori Infection
  • Helicobacter pylori
  • Gastric cancer
  • single nucleotide polymorphism
  • Stomach Neoplasms
  • Helicobacter Infections