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The Revolutions of Helicobacter Pylori Infection, Bacterial Density, and Histological Features After Antrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441831
Recruitment Status : Unknown
Verified February 2009 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2007
Last Update Posted : February 5, 2009
Information provided by:
Mackay Memorial Hospital

Brief Summary:
Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged supporting the link between the chronic gastritis of HP infection and malignancy in adults, specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the prevention of gastric cancer was underlined. At the national consensus meeting held in Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer diseases, regardless of activity, complication and post endoscopic resection of early cancer. Some patients received gastric surgery due to the complications of peptic ulcer such as bleeding or perforation in the pre-HP eradication era. Their HP infection status was not surveyed and unknown at the time. Afterward, some of them were not suggested to receive an eradication therapy and recovered from the operative procedure. According to the consensus to treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under risk. There have been only a few surveys on the prevalence of persistent HP infection in patients who have undergone surgery. The aim of the study was to evaluate the prevalence and histological features of HP infection after a time course of partial distal gastric surgery.

Condition or disease
Helicobacter Pylori Infection Peptic Ulcer Bile Reflux Gastritis

Detailed Description:

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 incidence.

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.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : February 2007
Estimated Study Completion Date : February 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with previous distal gastrectomy

Inclusion Criteria:

  • Previous distal gastrectomy

Exclusion Criteria:

  • Post HP eradication therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441831

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Contact: Wan-Ting Chen 886-2-25433535 ext 2485

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Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Ming-Jen Chen, M.D., M.S.    886-2-25433535 ext 2260   
Principal Investigator: Ming-Jen Chen, M.D., M.S.         
Sponsors and Collaborators
Mackay Memorial Hospital
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Principal Investigator: Ming-Jen Chen, M.D.,M.S. Mackay Memorial Hospital

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Responsible Party: Mackay Memorial Hospital, secretary, Mackay Memorial Hospital Identifier: NCT00441831     History of Changes
Other Study ID Numbers: MMH-I-S-261
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by Mackay Memorial Hospital:
Helicobacter pylori infection
peptic ulcer disease
distal partial gastrectomy
bile reflux

Additional relevant MeSH terms:
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Communicable Diseases
Helicobacter Infections
Peptic Ulcer
Bile Reflux
Gram-Negative Bacterial Infections
Bacterial Infections
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Biliary Tract Diseases
Duodenogastric Reflux