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临床试验/NCT01583699
NCT01583699已完成不适用

Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Qualitative MALT-features on Endomicroscopy

研究概览

简要总结

Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) represents a distinct clinical entity and is the most common form of extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen leads to regression of the tumor in a high percentage of patients at early tumour stages. Nevertheless, following complete remission after HP-eradication, the risk of relapse justifies lifelong follow-up examinations. Supported by recent findings at the investigators department, endoscopic controls should include a close examination of the small bowel, as relapses can involve different gastrointestinal sites. To continue the investigators diagnostic approach as well as to further improve the detection rate of MALT-lymphoma relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE) into the diagnostic management of MALT-lymphoma patients. In the context of a prospective clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will undergo staging or follow up endoscopies at the investigators department, to the histological evaluation of biopsy samples as present gold standard, the investigators want to determine whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma and healthy subjects should serve as controls. In comparison to random biopsies which represent the current standard, the investigators aim to prove, whether endomicroscopy will find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary biopsies.

详细描述

Introduction

Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) is the most common form of extranodal lymphoma [1, 2]. Although MALT-lymphoma may involve different organs, the stomach represents the site of predilection of this malignant disease. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) [3] and eradication of the pathogen leads to tumor regression in a high percentage of patients at early tumor stages [4, 5]. Relapses after HP-eradication and primary advanced tumor stages require chemotherapeutic treatment, radiation therapy and, in some cases, surgery [6]. Following complete remission lifelong follow-up examinations should be performed in order to detect relapses [7].

Histologically, MALT-lymphoma is characterized by an infiltration of the lamina propria by lymphomatous centrocyte-like cells that spread into the surrounding mucosal layers [8]. In immunohistochemistry they show CD 20 positive staining properties. When they spread to lymph nodes or spleen they accumulate typically within the marginal zone (for this reason they are classified as "marginal zone lymphoma") [2]. Dissemination to other organs, especially to other mucosal sites may occur frequently wherefore detailed diagnostics are required during MALT-lymphoma staging and follow-up. Spreading within the gastrointestinal tract (GI-tract), to the small bowel, for example, is rare, but can be assessed very easily with standard endoscopic procedures as recently reported at our department [9].

For gastric MALT-lymphoma gastroscopy with biopsy assessment is the current follow-up examination of choice. Multiple biopsies should be taken randomly from all gastric sites and specifically from all suspicious lesions. Recent developments for the enhancement of the tissue contrast during the endoscopic examinations (chromoendoscopy or Narrow Band Imaging, for example) helped to detect MALT-lymphoma lesions. Nevertheless, detection rates hardly changed, since all these techniques rely on the presence of superficial features[10].

An endoscopic technique that allows an evaluation of deeper wall layers is endoscopic ultrasonography. During the last years it has become an important amending tool in the diagnostic management of gastric MALT-lymphoma. Although it provides essential information about tumor infiltration depth and lymph node involvement in the context of staging procedures, it cannot replace histological assessment during follow-up, since endosonographic findings do not show a good correlation to histological results over time [11, 12].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to our department for upper endoscopy in the context of staging or follow-up of gastric MALT-lymphoma.
  • Exclusion criteria:
  • patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
  • refusal to participate in the study
  • patient's age below 18 years

排除标准

  • 未提供

结局指标

主要结局

Qualitative MALT-features on Endomicroscopy

时间窗: 2 years

Establishing endomicroscopic features of MALT-lymphoma in the upper gastrointestinal tract. This outcome is a qualitative endpoint that will be assessed only descriptively.

次要结局

  • Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Werner Dolak, MD

Principal Investigator

Medical University of Vienna

研究点 (1)

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