Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of Mucosa-associated Lymphoid Tissue Type of The Stomach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma.
研究概览
简要总结
To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1 primary low-grade B cell lymphoma of MALT of the stomach
详细描述
To investigate the prevalence of H. pylori infection in patients with early stage of primary low-grade B cell lymphoma of MALT of the stomach in Taiwan.
-To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1 primary low-grade B cell lymphoma of MALT of the stomach.
To evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma.
To estimate any differences in therapeutic efficacy related to different stage of disease,eg. stage IE v.s. stage IIE-1.
To identify the causes of treatment failure, such as the stage of tumor, the presence of large cell component, and/or persistent, reactivation or reinfection of H. pylori etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients must have histologically confirmed primary low-grade B-cell lymphoma of MALT of the stomach which including the following types : diffuse small lymphocytic, diffuse small cleaved, and some diffuse mixed small and large cell types by Working Formulation (Harris NL et al. 1994)(20).
- •The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :
- •No enlargement of peripheral or mediastinal lymph node;
- •Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;
- •Predominant of alimentary tract lesions with any adenopathy corresponding to accepted lymphatic drainage route; and
- •No involvement of liver or spleen except by extension of contiguous disease .
- •The monoclonality of B-cell must be confirmed by either immunohisto- chemistry (light-chain restriction) or molecular technique (IgH rearrangement).
- •The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALToma.
- •Patients must have evaluable disease by endoscopy and the nodal status by computed tomography. Endoscopic ultrasonography (EUS)* is optional and for reference only.
- •H. pylori infection will be evaluated by the following tests: histology, rapid urease test (CLO-test), and serology C13-urea breath test (UBT) and bacterial culture* are optional and for reference only.
- •The following will be considered to have H. pylori infection : at least two of the following 3 tests show positive results, rapid urease test (CLO-test), histology and serology.
- •For C13-urea breath test, rapid urease test and histology to examine H. pylori, the examination must be performed at least 4 weeks apart from the latest antibiotics or non-steroid anti-inflammatory drug ingestion.
- •Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Abor staging system modified by Musshoff for primary extranodal lymphoma.
- •Stage IE : lymphoma confined to the gastric wall without lymph node involvement.
- •Stage IIE : localized involvement of one or more GI site(s) on one side of the diaphragm with lymph node infiltration, any depth of lymphoma infiltration into the gut wall.
- •Stage IIE-1 : infiltration of adjacent lymph node.
- •Patient must have signed the informed consent.
排除标准
- •Patients who have extensive gastrointestinal tract involvement are not eligible.
- •Patients who have had previous history of extranodal lymphoma are not eligible.
- •Patients who have disease beyond stage IIE-2: infiltration of regional lymph node, e.g. paraaortic, renal hilar, retroperitoneal, mesenteric, or lymph node of gastrosplenic ligment and of hepatoduodenal ligment are not eligible.
- •Patients who had a history of allergic reaction to Amoxicillin and Erythromycin /Clarithromycin are not eligible.
- •Patients whose cardiopulmonary status not allow him/her to have repeat endoscopy are not eligible.
- •Patients who had prior surgery, chemo- or radiotherapy for their primary gastric lymphoma are not eligible.
- •Patients who had previous anti-H. pylori therapy are not eligible.
结局指标
主要结局
evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma.
时间窗: Four weeks after the completion of anti-H. pylori therapy by CT scan
Four weeks after the completion of anti-H. pylori therapy, patients shall have repeat endoscopy and abdominal CT to evaluate the H.pylori status and the response of MALToma.
次要结局
- objective regression rate and time to disease progression of primary low-grade gastric MALToma.(3-6 months by EUS)