Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: Helicobacter pylori eradication Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer |
- Histological grading improvement rate [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 190 |
| Study Start Date: | July 2003 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: H. pylori eradication |
Drug: Helicobacter pylori eradication
Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
|
| Placebo Comparator: placebo |
Drug: placebo
Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| Research Institute and Hospital, National Cancer Center | |
| Goyang, Gyeonggi, Korea, Republic of, 410-769 | |
| Principal Investigator: | Il Ju Choi, M.D., Ph.D. | National Cancer Center, Korea |
More Information
No publications provided
| Responsible Party: | Il Ju Choi, M.D., Ph.D., National Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01002443 History of Changes |
| Other Study ID Numbers: | NCCCTS03-063 |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 26, 2009 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by National Cancer Center, Korea:
|
Helicobacter pylori glandular atrophy intestinal metaplasia |
subtotal gastrectomy gastric cancer Precancerous lesion of gastric cancer |
Additional relevant MeSH terms:
|
Stomach Neoplasms Metaplasia Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013