跳至主要内容
临床试验/NCT01544452
NCT01544452终止不适用

Prospective Randomized Study of Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年8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
终止
入组人数
75
试验地点
1
主要终点
Synchronous colon cancers and liver metastasis

研究概览

简要总结

Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic evaluation before surgery. MR colonography have been shown to have high sensitivity and specificity for larger polyps and cancer and MRI of the liver have been shown to have similar or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of two or three different methods of evaluation. The investigators hypothesis is that the total MR evaluation is equal or superior to the existing preoperative evaluation regarding the diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the total diagnostic evaluation.

详细描述

Colorectal cancer (CRC) is among the most common cancer forms in Denmark with an approximate of 4300 new cases in Denmark annually, of which rectal cancer represents approximately 1400 new cases each year. It is also well known that synchronous cancer and polyps are present in up to 11% and 58% respectively in patients with CRC. It is assumed that adenomas constitute a precursor for cancer and it is thus speculated that the detection and removal of the adenoma could reduce the incidence and mortality of colorectal cancer. Danish Colorectal Cancer Group (DCCG) and the Danish Surgical Society (DKS) currently recommend full colonic investigation as part of the preoperative assessment, which also includes MRI of the rectum, ultrasound of the liver and chest X-ray (or abdominal /chest CT) to locate possible metastasis or synchronous tumors. However, it is often difficult to implement the preoperative colonic investigation due to lack of capacity or tumor stenosis. A recent Danish study showed that up to 78% of all patients with colorectal cancer had not received the full colonic investigation preoperatively. In this instance the recommendation from DCCG & DKS is that patients in the absence of complete colonic investigation preoperatively, should undergo colonoscopy within 3 months postoperatively.

Within the last 15 years new non-invasive imaging techniques have been developed, this includes MR colonography (MRC). Like conventional colonoscopy, MRC requires bowel cleansing, since feces can create artifacts that can hide or mimic polyps and abnormalities. After cleansing the colon is distended by water using a rectal catheter. Since it is only water that needs to pass through a possibly stenotic colon segment, there is a better chance to successfully examine the entire colon compared to a colonoscopy. A recent study showed a 98% success rate using MRC to examine the entire colon in patients with CRC having colon stenosis. The MRC is preformed after the colon is fully distended with water and depending on the resolution needed the scan times are between 10 and 15 minutes. Data processing, reconstruction and analysis are made at an independent workstation.

The advantages of MRC are its non-invasive nature, short examination time, and the fact that sedation is unnecessary. This makes it possible for patients to be discharged directly after the imaging procedure as opposed to the necessity for admission after a colonoscopy until the effects of the sedative drugs have worn off. Furthermore, it is assumed that patient compliance is much higher in MRC, since almost every patient finds it less unpleasant than colonoscopy.

MRI of the liver is a well-known procedure that has shown good results in the diagnosis of hepatic metastases and primary cancers. Several studies have shown that it is equal or better than CT and ultrasound of the liver.

Currently there are no studies, which make the overall preoperative assessment by means of one investigating technique, namely MRI. The investigators have previously studied the sensitivity/specificity and patient satisfaction by MRI colonography with fecal tagging. In this study the investigators want to investigate the quality of MR-colonography with bowel cleansing, also assessing the economical aspects of an overall examination of the rectum, colon and liver in patients with rectal cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Patients scheduled for operation for rectal cancer

排除标准

  • •Inflammatory bowel disease (IBD)
  • •Pacemaker
  • •Metal in the investigated areas
  • •Claustrophobia
  • •Age < 18 years
  • •Pregnancy
  • •Kidney disease
  • •Arrhythmia

研究组 & 干预措施

Total preoperative MR evaluation

Other

Total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session combined with CT thorax

干预措施: MR colonography and MR of the liver (Procedure)

Standard diagnostic evaluation

Other

Standard preoperative diagnostic evaluation for patients with rectal cancer, incl. CT thorax, abdomen and MRI of the rectum and colonoscopy

干预措施: Standard diagnostic evaluation (Procedure)

结局指标

主要结局

Synchronous colon cancers and liver metastasis

时间窗: 2013 (up to 4 years)

次要结局

  • sensitivity/specificity of CT versus MR versus Peroperative ultrasonography of the liver(2013 (up to 4 years))

研究者

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

Michael Achiam

Senior Resident, M.D., ph.d.

Herlev Hospital

研究点 (1)

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