Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Mackay Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00441831
First received: February 27, 2007
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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
Helicobacter Pylori Infection
Peptic Ulcer
Bile Reflux
Gastritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Estimated Enrollment: 65
Study Start Date: February 2007
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   15 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with previous distal gastrectomy

Criteria

Inclusion Criteria:

  • Previous distal gastrectomy

Exclusion Criteria:

  • Post HP eradication therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441831

Contacts
Contact: Wan-Ting Chen 886-2-25433535 ext 2485 wanting.b352@ms1.mmh.org.tw

Locations
Taiwan
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    mingjen.ch@msa.hinet.net   
Principal Investigator: Ming-Jen Chen, M.D., M.S.         
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Ming-Jen Chen, M.D.,M.S. Mackay Memorial Hospital
  More Information

Publications:
Responsible Party: Mackay Memorial Hospital, secretary, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT00441831     History of Changes
Other Study ID Numbers: MMH-I-S-261
Study First Received: February 27, 2007
Last Updated: February 4, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014