Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Helicobacter pylori eradication
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Helicobacter pylori, glandular atrophy, intestinal metaplasia, subtotal gastrectomy, gastric cancer, Precancerous lesion of gastric cancer
Eligibility Criteria
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
Sites / Locations
- Research Institute and Hospital, National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
H. pylori eradication
placebo
Arm Description
Outcomes
Primary Outcome Measures
Histological grading improvement rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01002443
First Posted
October 26, 2009
Last Updated
October 26, 2009
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01002443
Brief Title
Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Official Title
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Helicobacter pylori, glandular atrophy, intestinal metaplasia, subtotal gastrectomy, gastric cancer, Precancerous lesion of gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H. pylori eradication
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Helicobacter pylori eradication
Intervention Description
Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days
Primary Outcome Measure Information:
Title
Histological grading improvement rate
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute and Hospital, National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23822578
Citation
Cho SJ, Choi IJ, Kook MC, Yoon H, Park S, Kim CG, Lee JY, Lee JH, Ryu KW, Kim YW. Randomised clinical trial: the effects of Helicobacter pylori eradication on glandular atrophy and intestinal metaplasia after subtotal gastrectomy for gastric cancer. Aliment Pharmacol Ther. 2013 Sep;38(5):477-89. doi: 10.1111/apt.12402. Epub 2013 Jul 3.
Results Reference
derived
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Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
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