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15 Years
95 Years
Open (Enrolling)
Helicobacter Pylori Infection, Peptic Ulcer, Bile Reflux, Gastritis

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Trial Information

The eradication of H pylori is known to reduce the recurrence rate of peptic ulcer and
gastric inflammation. But it is still not clear about the prevalence of HP infection in
patients after surgical interventions when the micro-environment had been changed. Since
biliary enterogastric reflux is suggested to inhibit the growth of HP, we will investigate
in a prospective study the effect of partial gastrectomy on the influence of HP infection

Patients with previous distal gastrectomy will be prospectively evaluated as study group.
Same number of patients with the same indication of endoscopy evaluations and without
previous gastrectomy will be established as a normal control group for H pylori infection
rate comparison. All patients in study and control groups who had previously received H
pylori eradication therapy will be excluded. Three gastric biopsy specimens were collected
from each patient for histological analysis. Patients with a pre-operative biopsy, operative
specimen revealing H pylori colonization or a positive serum H pylori IgG will be indicated
previous H pylori infection and will be assessed the percentage of spontaneous clearance of
HP infection. A positive bile staining will indicate biliary enterogastric reflux. This
assessment will be made by two investigators, and disagreements will be resolved by joint
discussion to reach a consensus. Tissue sections stained with hematoxylin and eosin and the
Giemsa stain will be examined by pathologist who was unaware of the endoscopy findings.
Density of HP in the tissue and histological gastritis activity and intestinal metaplasia
will be graded as normal (0), mild (1), moderate (2) and severe (3) based on the Sydney
system. Follicular gastritis will be based on the absence (0) or presence (1) of lymphoid
follicules and lymphoid with germinal center (2).

The primary end point will be the change of infection rate on HP after distal gastrectomy
procedure comparing the normal control. The secondary end point will assess the correlation
between the duration of the antrectomy, the operative procedure, the severity of bile reflux
with the inhibition of HP growth. Finally, this study will be base on histopathological
features with the density of HP, the grading of gastritis activity, intestinal metaplasia
and follicular gastritis.

Inclusion Criteria:

- Previous distal gastrectomy

Exclusion Criteria:

- Post HP eradication therapy

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Principal Investigator

Ming-Jen Chen, M.D.,M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mackay Memorial Hospital


Taiwan: Department of Health

Study ID:




Start Date:

February 2007

Completion Date:

February 2008

Related Keywords:

  • Helicobacter Pylori Infection
  • Peptic Ulcer
  • Bile Reflux
  • Gastritis
  • Helicobacter pylori infection
  • peptic ulcer disease
  • distal partial gastrectomy
  • bile reflux
  • gastritis
  • gastrectomy
  • Bacterial Infections
  • Bile Reflux
  • Gastritis
  • Peptic Ulcer
  • Ulcer
  • Helicobacter Infections