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Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer


Phase 2
18 Years
70 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer


Helicobacter pylori (H. pylori) is a primary etiological agent leading to chronic gastritis
and peptic ulcer. The organism is also associated with gastric cancer in epidemiological
studies. However, detailed mechanism of carcinogenesis remains unknown. Histolopathological
studies indicate that chronic H. pylori infection progresses over decades through stages of
chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and
intestinal metaplasia are considered as precancerous lesions, but whether H. pylori
eradication improves these lesions is controversial. And the issue has not been evaluated in
gastric cancer patients. However, despite the lack of evidence proven by a well-designed
study, current guidelines from Europe and Japan recommend H. pylori eradication treatment in
patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is
important to evaluate whether H. pylori eradication can improve known precancerous lesion,
i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such
histological improvement may eventually reduce secondary gastric cancer development and
provide evidence for current guidelines. Helicobacter pylori is a primary etiological agent
leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric
cancer in epidemiological studies. However, detailed mechanism of carcinogenesis remains
unknown. Histolopathological studies indicate that chronic H. pylori infection progresses
over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia
and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous
lesions, but whether H. pylori eradication improves these lesions is controversial. And the
issue has not been evaluated in gastric cancer patients. However, despite the lack of
evidence proven by a well-designed study, current guidelines from Europe and Japan recommend
H. pylori eradication treatment in patients who were treated for gastric cancer by
surgically or endoscopically. Thus, it is important to evaluate whether H. pylori
eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal
metaplasia in gastric cancer patients. Such histological improvement may eventually reduce
secondary gastric cancer development and provide evidence for current guidelines.


Inclusion Criteria:



- AGC or EGC confirmed by endoscopy

- Histologically confirmed adenocarcinoma of stomach

- Helicobacter pylori infection was confirmed by biopsy and CLO

- Pre op CT stage: IA, IB, II, IIIA according to UICC TNM classification system

- Pre op biopsy (body LC side) shows either intestinal metaplasia or glandular atrophy
(at least grade 1)

- Tumor location is suitable for subtotal gastrectomy- i.e. at or distal to lower body

- Informed consent should be signed

Exclusion Criteria:

- Recurrent gastric cancer

- Previous serious side effect to antibiotics

- H. pylori eradication treatment history

- Other malignancy within the past 5 years

- Pregnant or nursing women

- Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal
failure, cardiovascular diseases

- Psychiatric disorder that would preclude compliance

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Histological grading improvement rate

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Il Ju Choi, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS03-063

NCT ID:

NCT01002443

Start Date:

July 2003

Completion Date:

March 2009

Related Keywords:

  • Gastric Cancer
  • Helicobacter pylori
  • glandular atrophy
  • intestinal metaplasia
  • subtotal gastrectomy
  • gastric cancer
  • Precancerous lesion of gastric cancer
  • Stomach Neoplasms
  • Metaplasia

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