Preoperative Assessment of Mesorectal Lymph Nodes by Dual Energy CT. PUMK-DECT
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- the detection of lymph nodes by DECT in specimens from rectal resection for cancer.
研究概览
简要总结
Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by DECT in operation specimens from rectal resection for cancer. sub project 2: Primary endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive- and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate the value of the gold standard for the use of imaging methods for the description of the lymph node, validated by histopathology. Secondary: to determine the value of tumor diagnostics using DECT.subproject 4: To assess the value of DECT as imaging tool for diagnosing response to chemo radiotherapy of malignant lymph nodes.
详细描述
Background Long-term survival for patients with cancer of the rectum (RC) is through the last 20 years dramatically improved from about 30% to 65% . Overall focus on disease with the creation of multidisciplinary teams, national quality databases certification of surgeons, etc. have contributed to the development especially in the last 10-15 years . The introduction of pre-operative Oncology, known as neoadjuvant treatment increased the survival rate by up to 10% in certain patient series. However, the prognosis remains poor for advanced cases, qua risk of metastasis and local cancer relapse.
Surgical treatment remains the cornerstone of curative treatment of RC. Total mesorectal excision (TME) includes resection of both the tumor and the surrounding mesorectal fat. TME is currently used as the gold standard for surgical treatment of RC. The use of TME has reduced local relapse rate to less than 10%.
TME surgery combined with preoperative chemotherapy and radiation therapy if the cancer is in an advanced stage (T3), and often with high-dose radiotherapy and chemotherapy in the most advanced cases of T-stage 4.
Complications of TME are present in more than 40% of patients. Most often in the form of wound dehiscence, infection, sexual dysfunction, bowel disorders and the necessity of a stoma. More than 50% of patients have permanently reduced quality of life.
Minimally invasive therapies (trans-anal endoscopic microsurgery (TEM)) for the curative treatment of early rectal cancers, is well-validated. The complication rate is low, and above all, the operative mortality of less than 1% even in the elderly and patients with comorbidities, opposed to 10% at standard surgery. The use of TEM surgery early in the rectum cancers in selected patients will thus be able to reduce the risk of complications and improve the overall long-term survival. Even though the disease-specific survival is reduced due to a less radical procedure. The Danish screening program for colorectal cancer will result in a significant increase in the detection of early cancers.
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
- 否
入选标准
- •All patients with an endoscopic suspected rectal cancer.
排除标准
- •Chronic kidney failure
- •pregnancy
- •rectal cancer recurrence
- •known contrast allergies
研究组 & 干预措施
dual energy ct
干预措施: Dual energy computed tomography (Device)
结局指标
主要结局
the detection of lymph nodes by DECT in specimens from rectal resection for cancer.
时间窗: 6 months
Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.
sensitivity and specificity for the detection of malignant lymph nodes in vitro RC specimens compared with histopathology
时间窗: 6 months
Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.
sensitivity, specificity, positive- ognegative predictive values, accuracy of DECT and standard MRI.
时间窗: 1 year
Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations. Histopathological proved malignant lymph nodes will be compared to histopathological proved benign lymph nodes.
DECT as imaging tool for diagnosing response to chemo radiotherapy of malignant lymph nodes, and tumors.
时间窗: 1 year
Rectal Cancer Regression Grade (RCRG) according to the three levels RCRG 1-3. RCRG 1: the tumour is either sterilised or only microscopic foci of adenocarcinoma remain; RCRG 2: marked fibrosis, but with macroscopic tumour still present; and RCRG 3: little or no fibrosis in the presence of abundant macroscopic tumour , based on measurments of Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.
次要结局
未报告次要终点
研究者
Issam al-Najami
MD
Odense University Hospital
