Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy in T stage
研究概览
简要总结
The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection.
详细描述
Over the last years a significant improvement in the treatment of patients with colon cancer has been reported. This has been attributed to the improvement of the staging techniques, as well as the optimization of the surgical management. However, the current five-year survival rates of colon cancer patients in European countries ranges from 32% to 64%. This variation could be due to treatment discrepancies and the lack of adherence to the international guidelines.
Surgical treatment of colon cancer includes the radical resection of the tumour (colectomy). Following resection, the specimen is histopathologically examined, the disease is staged and further treatment is determined. Neoadjuvant treatment (radiotherapy or/and chemotherapy) for colon cancer has not been yet approved, unlike rectal cancer, where neoadjuvant treatment is recommended for specific disease stages.
Preoperative staging of colon cancer aims to identify those patients with remote metastatic disease, who will, more likely, not benefit from upward surgery. Recent developments in colon cancer management, demanding more precise local disease staging, to identify those patients who will likely benefit from neoadjuvant chemotherapy, are still at a clinical trial stage.
Preoperative treatment depends on the disease stage, which is defined by the tumour's invasion in the colonic wall, the dissemination in nearby organs or lymph nodes, and the presence of distal metastases. The stage is first evaluated radiologically and then confirmed via histopathological examination of the specimen. Imaging is an already approved tool for the staging of colonic cancer, while in some studies the combination of different imaging methods has been reported to improve the initial evaluation.
Over the last years, evaluation of the circumferential resection margin (CRM) is also recommended in the preoperative staging of patients with colon cancer. This assessment is particularly important for tumours located at the cecum, right, or left colon, since these areas lack of mobile mesocolon and therefore it is possible to infiltrate the retroperitoneal resection margin.
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
盲法说明
There will be no blindness at the level of the patient, the treating physicians (surgeon, oncologist, radiologist) and the researcher who will record the data
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colonic adenocarcinoma
- •Patient 18 to 90 years old
- •Abscence of comorbidities that may affect treatment
- •Signed informed consent of the patient
排除标准
- •Inability to receive or contraindication for intravenous contrast
- •Renal impairment
- •Previous allergies to intravenous contrasts
- •Incompatible implants with magnetic resonance imaging
- •Claustrophobia
- •Active sepsis or systemic infection
- •Untreated physical and mental disability
- •Lack of compliance with the protocol process
- •Non-granting of signed informed consent
结局指标
主要结局
Diagnostic accuracy in T stage
时间窗: 1 month postoperatively
Evaluation of diagnostic accuracy in the T stage assessment. Diagnostic accuracy will be evaluated in terms of specificity (true negative rate)
次要结局
- Diagnostic accuracy in the retroperitoneal resection margin(1 month postoperatively)
- Diagnostic accuracy in N stage(1 month postoperatively)
- Diagnostic accuracy in peritoneal or nearby organ infiltration(1 month postoperatively)
研究者
Effrosyni Bompou
Effrosyni Bompou Principal Investigator
Larissa University Hospital