Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Incidence of metachronous gastric cancer
研究概览
简要总结
This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.
详细描述
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 and prevents metachronous gastric cancer is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions 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 can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early Gastric cancer or high grade dysplasia confirmed by endoscopy
- •Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia
- •Submucosal invasion is not suspected
- •No evidence of ulceration or ulcer scar within the lesion
- •Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test
- •Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system
- •Informed consent should be signed
排除标准
- •Recurrent gastric cancer
- •Previous serious side effect to antibiotics
- •H. pylori eradication treatment history
- •Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
- •Undergoing operation due to complication of EMR
- •Undergoing operation due to remnant cancer
- •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
研究组 & 干预措施
7 day H.pylori eradication
Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
干预措施: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin (Drug)
Placebo
Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days
干预措施: Placebo, Omeprazole or Rabeprazole, Clarithromycin (Drug)
结局指标
主要结局
Incidence of metachronous gastric cancer
时间窗: 3 years after last patient enrollment
Comparison of metachronous gastric cancer according to the allocated treatment
Improvement (histological) of glandular atrophy
时间窗: 3 years after enrollment
Improvement of glandular atrophy at the corpus lesser curvature
次要结局
- Incidence of new gastric dysplasia(3 years after last patient enrollment)
- Overall survival(3 years after last patient enrollment)
研究者
Il Ju Choi
MD, PhD
National Cancer Center, Korea