The Value of Laparoscopic Ultrasound in Patients Undergoing Laparoscopic Resection for Cancer of the Colon or Rectum: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 8
- 主要终点
- A change in the stage of Tumor, lymph Node and metastases (TNM-stage)
研究概览
简要总结
The following project deals with a Danish multicenter trial that evaluates the value of Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum cancer (CRC).
The project "The value of laparoscopic ultrasound in patients undergoing laparoscopic resection for colon and rectum cancer. - A prospective randomized trial" is part of a ph.d- study at the University of Southern Denmark in collaboration with several surgical departments at hospitals in Southern Denmark.
The primary purpose is to investigate whether the use of laparoscopic ultrasound examination (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC).
As a secondary objective; an evaluation of the use of LUS will change the treatment strategy for the individual patient with CRC.
As an other objective we wants to investigate whether the use of contrast enhanced ultrasound examination in connection with LUS procedure increases the number of detected liver metastases.
详细描述
Laparoscopic surgery for cancer in the colon or rectum seems to be equal standing to open surgery with regards to the morbidity, mortality and the oncologic results (radicality and re-lapse frequency and long-term survival). Laparoscopic surgery for colon and rectum cancer is now a well-understood and well-established surgical method, but there are only few randomized trials dealing with the long-term results. The latest inventory work calls for better documentation of long-term results and calls for further randomized studies. Despite this, the number of laparoscopic operations for colorectal cancer (CRC) in Denmark is increasing, and laparoscopic surgery has partially become established as standard treatment for CRC.
Liver metastases are frequent in patients with CRC and about 15-20% of patients already have metastases at the diagnosis. Ultrasound examination during open surgery (IOUS) has shown to be an important diagnostic tool with high sensitivity (98%) and positive predictive value (86%) for detection liver metastases that are undiagnosed on preoperative computed tomography scan (CT) or Positron emission tomography-computed tomography scan (PET-CT). IOUS is considered as the gold standard for hepatic metastases within open surgery for CRC. In laparoscopic surgery this option disappears, but it is likely that Laparoscopic Ultrasound examination (LUS), may provide the same information as found by IOUS.
While laparoscopy and laparoscopic ultrasound examination (LUS) is well established in the staging and treatment of upper gastrointestinal cancers, this method is only sparsely evaluated in the treatment of CRC. There are only very few and older data dealing with the use of LUS in the Tumor - lymph Node and Metastases (TNM) staging in patients with cancer in the colon and rectum. Several small studies have investigated the use of LUS to evaluate the M-stage in laparoscopic colorectal surgery and all studies show an increased detection of liver metastases. Overall, seems LUS to be better than the current pre-operative image modalities, and the LUS and the IOUS has also been found to be able to locate small tumors in the colon.
Based on the above, a recent review concluded that the data about the routine use of laparoscopy and LUS in patients with CRC are not sufficient, but that LUS probably could be used for assessment of the liver, liver-metastases and non-regional lymph nodes. There are no randomized studies dealing with the use of LUS in laparoscopic surgery for CRC.
It is not a standard routine to use LUS of the liver, tumor and retroperitoneum during laparoscopic surgery for CRC.
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 with colon and rectum cancer without known metastasis
- •Patients who gives informed consent
- •Patients who are referral to laparoscopic surgery
排除标准
- •Patients who are not able to give informed consent
- •Patients who are under 18 of age Patients with known metastasis.
- •Patients who are allergic to contrast agents
- •Patients who are pregnant or lactating
结局指标
主要结局
A change in the stage of Tumor, lymph Node and metastases (TNM-stage)
时间窗: 3 months
When using laparoscopic ultrasound examination (LUS) during laparoscopic resection for colon and rectum cancer, it is possible to scan the tumor, lymph nodes around the tumor, retroperitoneum and the liver. Thereby it is possible to make a preoperative TNM staging. Will the use of LUS change the stage of Tumor lymph Node and Metastases (TNM stage) compared to the preoperative TNM evaluation. The procedure LUS takes approximately 5 to 10 minutes. Tree months after surgery the patients will get a CT scan of the liver to ensure that the LUS did not miss any metastasis.
次要结局
- A change in the postoperative treatment strategy(3 months)
研究者
MD Signe Bremholm Rasmussen
MD
Odense University Hospital