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临床试验/NCT02324023
NCT02324023已完成不适用

Endoscopic Ultrasound Scanning and Contrast Enhancement for Staging and Evaluation of Angiogenesis of Left Sided Colon Cancers

Zealand University Hospital4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年11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
35
试验地点
4
主要终点
T-stage in left sided colonic cancer determined by endoscopic ultrasound compared to histological stage

研究概览

简要总结

Cancer in the colon and rectum represents a global health burden being the most common cancer of the digestive tract. It is the second most common cancer in Denmark and only about half of the patients survive this diagnosis. Thorough characterization of the tumour preoperatively is very important, since it determines if the patient should be treated with chemotherapy before operation and, in the future, which operation would be most suitable for the patient.

Research has shown that endoscopic ultrasound (EUS) is superior to a CT-scan, in determining the local growth of the tumour in rectal cancer. Today, a CT-scan is the image modality of choice, and is used in all Danish hospitals when it comes to colon cancer. Hopefully, the investigators can apply EUS in colon cancer patients and thereby alter our diagnostic approach, towards a quicker and safer way to determine which treatment the investigators should offer the patient.

With the screening programme for colorectal cancer in Denmark the investigators will find more and more cases of colorectal cancers, especially in the early stages, before symptoms begin. These small tumours put doctors in several dilemmas concerning the strategy of treatment. Even today, the investigators are very reluctant in offering large-scale operations to elderly and fragile patients who have been diagnosed with cancer in the rectum. Instead, local endoscopic operations are performed in selected patients. This approach has not yet been tried in early colonic cancers. However, it might turn out that local, endoscopic surgery will show to be beneficial for patients with colon cancers and maybe even decrease morbidity, mortality and the regenerative period after surgery.

The aim of this PhD-project is to investigate the utility of the EUS-method in characterizing tumours in the colon and in investigating the blood flow in the tumour.

详细描述

Introduction Background: Colorectal carcinoma represents a global health burden being the most common cancer of the digestive tract. The lifetime risk of developing colorectal carcinoma is 5%, while the overall number of patients currently alive with diagnosed disease in Denmark is estimated to be 30.000 patients. Approximately 70% of cases involve the colon, with the remaining 30% involving the anus and rectum. The mortality rate is intimately related to its high metastatic ability and therefore prognosis strongly depends on the stage at diagnosis.

Angiogenesis: Angiogenesis plays an important role in tumour growth and its metastatic potential and it has been attracting a lot of attention in the past years, due to possible implications in prognosis stratification, as well as in the targeted treatment of advanced colorectal cancer. Most cancers depend firmly on the development of a new capillary network to allow nutrition of newly formed tumour cells. These newly developed blood vessels are usually highly permeable and allow the access of tumour cells in the general circulation, leading to metastatic progression. Current treatment strategies for patients with advanced colorectal cancer include a combined regimen of cytotoxic and biologic therapy targeting angiogenesis. Thus, there is a great interest in finding alternative imaging tests for assessing the efficacy of antiangiogenic agents earlier in the course of therapy, based on functional imaging of tumour vascularity. The benefit that is seen in the survival of patients with advanced disease by treatment with antiangiogenic drugs can maybe translate in a neoadjuvant setting or an adjuvant setting in patients with stage III cancer or high risk stage II cancer.

Staging: Tumour is described by the TNM classification of malignant tumours (TNM).

Accurate preoperative staging of colon and rectum cancer is the main factor determining the treatment modality for patients and can greatly influence the results. Prognostication and determination of T stage of colon tumours by using computed tomography (CT) scans have been widely discussed in the literature. Endoscopic ultrasound (EUS) has been suggested the staging tool of choice for rectal cancer, when comparing to CT, yet colonic cancers remain to be investigated.

With the Danish National Bowel Cancer Screening Programme, increasing numbers of early cancers are revealed. During recent years local treatment in patients with rectal carcinoma in situ T0 or (T1/T2N0M0) cancers has become more and more accepted and has opened new avenues in treatment of old, comorbid or in other ways, vulnerable patients. As a result of the screening programme clinicians will naturally be placed in new dilemmas in terms of treatment choices, radical versus local excision, for early colonic cancers. Important issues on colonic cancer excisions, are the intramural extent of invasion and the presence or absence of lymphnode metastasis.

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 planned for elective left-sided colon cancer surgery
  • Age 18 to 100 years old, men or women
  • Signed informed consent for EUS with contrast-enhancement

排除标准

  • Prior treatment with chemo-radiotherapy (before the diagnosis of colon cancer)
  • Prior endoscopic resection or attempted endoscopic resection (before the diagnosis of colon cancer, but in the same area as the cancer)
  • Pregnant women
  • Failure to provide informed consent
  • Severe coagulopathy

结局指标

主要结局

T-stage in left sided colonic cancer determined by endoscopic ultrasound compared to histological stage

时间窗: EUS examination, 10 min

EUS stage compared to histological stage and CT scan stage

次要结局

  • Perfusion in left sided colonic cancer determined by contrast enhanced endoscopic ultrasound compared to histological vascular immunostaining(CE-EUS examination, 5 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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