MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Percentage of patients who needed additional radiology examination/s before treatment planning after routine MRI of abdominal organs compared with routine CT of abdominal organs.
研究概览
简要总结
Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio-frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels.
The aim of this study is to examine the possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
详细描述
Background:
Rectal cancer is a common diagnosis in both men and women, more commonly occurring in men (60%) than women (40%). In Sweden some 2000 cases are diagnosed each year. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery.
For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients in the Swedish Colo- Rectal Cancer Registry (SCRCR) and treated for rectal cancer at Sahlgrenska University Hospital and Norra Älvsborg Hospital 2013-2015.
排除标准
- 未提供
结局指标
主要结局
Percentage of patients who needed additional radiology examination/s before treatment planning after routine MRI of abdominal organs compared with routine CT of abdominal organs.
时间窗: 3 months
次要结局
- Cost effectiveness analysis of routine MRI of abdominal organs compared with routine CT of abdominal organs.(3 years)
- Comparison of the percentage of patients who were diagnosed with liver metastasis, between the two groups.(3 years)
- Disease free survival after 3 years(3 years)
- Comparison of percentage of patients treated with liver surgery/ablation within 12 months between the two groups.(12 months)
- Overall survival after 3 years(3 years)
研究者
Mattias Prytz
Principal Investigator
Sahlgrenska University Hospital, Sweden