- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441831
The Revolutions of Helicobacter Pylori Infection, Bacterial Density, and Histological Features After Antrectomy
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wan-Ting Chen
- Phone Number: 2485 886-2-25433535
- Email: wanting.b352@ms1.mmh.org.tw
Study Locations
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Taipei, Taiwan
- Recruiting
- Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital
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Contact:
- Ming-Jen Chen, M.D., M.S.
- Phone Number: 2260 886-2-25433535
- Email: mingjen.ch@msa.hinet.net
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Principal Investigator:
- Ming-Jen Chen, M.D., M.S.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Previous distal gastrectomy
Exclusion Criteria:
- Post HP eradication therapy
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ming-Jen Chen, M.D.,M.S., Mackay Memorial Hospital
Publications and helpful links
General Publications
- Fukuhara K, Osugi H, Takada N, Takemura M, Lee S, Taguchi S, Kaneko M, Tanaka Y, Fujiwara Y, Nishizawa S, Kinoshita H. Duodenogastric reflux eradicates Helicobacter pylori after distal gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1548-50.
- Huang WH, Wang HH, Wu WW, Lai HC, Hsu CH, Cheng KS. Helicobacter pylori infection in patients with ulcer recurrence after partial gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1551-3.
- Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
- Johannesson KA, Hammar E, Stael von Holstein C. Mucosal changes in the gastric remnant: long-term effects of bile reflux diversion and Helicobacter pylori infection. Eur J Gastroenterol Hepatol. 2003 Jan;15(1):35-40. doi: 10.1097/00042737-200301000-00007.
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Duodenal Diseases
- Biliary Tract Diseases
- Duodenogastric Reflux
- Gastritis
- Infections
- Helicobacter Infections
- Peptic Ulcer
- Bile Reflux
Other Study ID Numbers
- MMH-I-S-261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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