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临床试验/NCT01684514
NCT01684514已完成不适用

Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
CLE findings are recorded and compared with the findings of conventional colonoscopy (Mayo score), including observations for the control group

研究概览

简要总结

Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures in vivo. The examination is carried out with a confocal laser endomicroscope, which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has potential to replace conventional microscopy and the dynamic nature of the procedure allows visualization of structures and cellular processes in almost real-time. This provides us with a potentially new diagnostic tool with a promising future. To date only a few studies have been published on inflammatory bowel disease (IBD) and in the literature high-quality research is still lacking.

The project consists of a blinded prospective observation and methodology study including inter- and intra-observation of patients with proctitis before and after initiation of local treatment.

Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation and treatment response in patients with ulcerative colitis and is a sensitive supplementary to conventional diagnostics.

详细描述

Confocal laser endomicroscopy findings in patients with proctosigmoiditis before and after initiation of treatment

Background Inflammatory bowel disease (IBD) includes Crohn's disease and ulcerative colitis. Crohn's disease often strikes the terminal ileum, but may occur from the mouth to the anus. It is characterized by segmental spreading with transmural inflammation and occasional presence of granulomas in the tissue samples. Ulcerative colitis is only found in the colon and involves in practice always the rectum. The inflammation is limited to the mucosa and submucosa, and the diffusion is continuous.

The development of endoscopy has made these procedures a central part of the diagnostic and therapeutic management of patients with gastrointestinal diseases, including IBD. The entire gastrointestinal tract is now available for inspection and therapy. A limitation of these studies is that the histology, which is often essential for the diagnosis and treatment of the patient, cannot always be precisely evaluated by a conventional examination. The proper handling of detected lesions require in addition to the endoscopic evaluation, a histological evaluation of the tissue involved, making tissue samples necessary in order to obtain a definitive diagnosis and thus optimal handling. Therefore, during the endoscopic procedure tissue samples from the intestinal mucosa must be taken, which rarely involves a greater risk to the patient, but causes a delay, due to preparation time for the histological analysis and in some cases even due to re-examination if histopathology is negative. In the treatment of IBD the endoscopic assessment of the severity and extension is absolutely essential for the choice of treatment. The "Gold standard" for the optimal treatment is called "deep" remission, defined by clinical and endoscopic remission as assessed by conventional endoscopy.

Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an "optical biopsy", which can be compared with a similar microscopic image.

This provides us with a potential opportunity for immediate diagnosing and targeted therapy during the same procedure. The optical biopsy is stored digitally in such a way that it can also be evaluated postprocedure. During CLE multiple frames are generated per second, which is stored continuously, thereby forming a movie sequence, so that the microscopic assessment of the tissue becomes dynamic i.e. the flow in the small vessels may be observed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Patients with active proctitis or proctosigmoiditis due to ulcerative colitis, where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already in oral 5-ASA therapy, may be included.
  • •The control group will consist of patients without known or suspected IBD. Patients must be of legal age. Patients who have received written informed consent.

排除标准

  • •Increased p-creatinine and/or demonstrated allergy to fluorescein. Pregnant and lactating women. Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents.

研究组 & 干预措施

colitis, ulcerative

Experimental

Enrolled patients will be examined by conventional colonoscopy and confocal laser endomicroscopy before and after initiation of topical treatment, respectively.

干预措施: Confocal laser endomicroscopy (Device)

Control group

Sham Comparator

A control group will be examined by conventional colonoscopy and confocal laser endomicroscopy.

干预措施: Confocal laser endomicroscopy (Device)

结局指标

主要结局

CLE findings are recorded and compared with the findings of conventional colonoscopy (Mayo score), including observations for the control group

时间窗: The trial will go on for 2 years

CLE and colonoscopy findings are compared with the pathological evaluation of tissue samples.

时间窗: The trial will go on for 2 years

Intra-and inter-observer agreement between 3 CLE operators is calculated by kappa statistics

时间窗: The trial will go on for 2 years

次要结局

  • Effect of therapy with topical therapy, based on the results of the conventional colonoscopy and CLE(The trial will go on for 2 years)
  • Registering time of the procedure.(The trial will go on for 2 years)
  • Registering possible complications(The trial will go on for 2 years)

研究者

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

John Gasdal Karstensen

MD, ph.d.-student

Herlev Hospital

研究点 (2)

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