Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
October 26, 2009 updated by: National Cancer Center, Korea
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Helicobacter pylori (H.
pylori) is associated with gastric cancer in epidemiological studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial.The primary objective of this study is to evaluate whether Helicobacter pylori eradication improves glandular atrophy and intestinal metaplasia which are known to be precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi
-
Goyang, Gyeonggi, Korea, Republic of, 410-769
- Research Institute and Hospital, National Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
|
Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days
|
|
Active Comparator: H. pylori eradication
|
Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Histological grading improvement rate
Time Frame: 6 years
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Il Ju Choi, M.D., Ph.D., National Cancer Center, Korea
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
October 26, 2009
First Submitted That Met QC Criteria
October 26, 2009
First Posted (Estimate)
October 27, 2009
Study Record Updates
Last Update Posted (Estimate)
October 27, 2009
Last Update Submitted That Met QC Criteria
October 26, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCCTS03-063
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.