A Clinical Trial of Sentinel Lymph Node Biopsy in Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- False negative rate
研究概览
简要总结
Rectal cancer is one of the most common malignant tumors, with 9% to 23% of patients experiencing pelvic sidewall lymph node metastasis. According to the current Chinese guidelines for diagnosing and treating colorectal cancer, pelvic sidewall lymph node dissection is recommended for patients who have experienced or are suspected of having lateral lymph node metastasis. Lateral lymph node dissection can result in longer operation times, increased bleeding, and complications such as urinary and sexual dysfunction after surgery. Currently, the presence of metastasis is primarily determined by the size and enhancement characteristics of lateral lymph nodes observed through imaging studies. However, the pathological lymph node metastasis rate of specimens collected after lateral lymph node dissection based on current imaging criteria is only 20.5%. Therefore, a pressing clinical challenge is accurately determining the presence of lateral lymph node metastasis and avoiding unnecessary lateral lymph node dissection in patients who have not experienced lateral lymph node metastasis.
Sentinel lymph node biopsy has been widely used in clinical practice. It has replaced traditional lymph node dissection in some breast cancer and melanoma patients, reducing surgical risks and complications and improving patients' quality of life. This study aims to use indocyanine green as a tracer for fluorescence-guided laparoscopic navigation to locate the lateral sentinel lymph nodes of rectal cancer in the pelvic cavity. By studying the accuracy, specificity, and false-negative rate of predicting lateral lymph node status using the sentinel lymph node, we can further clarify the clinical significance of the lateral sentinel lymph node.
详细描述
This study is a prospective single-arm clinical study. 87 patients with middle and low rectal cancer are planned to be included in the study. After general anesthesia during the operation, indocyanine green is injected around the tumor through the anus. After the sentinel lymph nodes are developed and located by fluorescent laparoscopy, they are removed and sent to rapid frozen pathological examination, and then the lateral lymph nodes are cleaned. Through pathological examination and statistical analysis of the fluorescent stained lateral sentinel lymph nodes and all the cleaned lateral lymph nodes, To evaluate the clinical significance of lateral sentinel lymph nodes located by this technique in predicting the status of lateral lymph nodes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-
- •Newly diagnosed patients with confirmed rectal cancer by histopathology.
- •Preoperative clinical staging by imaging examination is T3-
- •Preoperative colonoscopy shows the distance from the tumor's lower edge to the anus is less than 10cm.
- •No previous chemotherapy or radiotherapy.
- •Preoperative imaging examination (pelvic enhanced MRI) shows lateral lymph nodes with a maximum short diameter of ≥5mm and <10mm.
- •Women of childbearing age must take effective contraceptive measures.
- •Able to understand the study and sign the informed consent form.
排除标准
- •Complete intestinal obstruction.
- •Active hepatitis and peripheral neuropathy (such as peripheral neuritis, pseudomeningitis, motor neuritis, sensory disturbances, etc.).
- •Pregnant or lactating women; women of childbearing potential who have not taken sufficient contraceptive measures.
- •History of other tumors or previous chemotherapy or radiotherapy.
- •Alcoholism or drug addiction.
- •Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation.
- •Hypoproteinemia.
- •Preprandial blood glucose control exceeds 11.2mmol/L in the week before surgery.
- •BMI>28 kg/m^
- •Poor compliance, and failure to comply with the study protocol.
- •Subject withdrawal from the study
研究组 & 干预措施
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: Sentinel lymph node biopsy (Procedure)
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: Indocyanine green solution (Drug)
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: fluorescence laparoscope (Device)
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: pathological examination (Diagnostic Test)
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: rapid frozen pathological examination (Diagnostic Test)
Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
干预措施: total mesorectal excision (Procedure)
结局指标
主要结局
False negative rate
时间窗: up to 14 days
The false negative rate of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer. Namely, the false negative rate= total false negative cases/(total false negative cases+total true positive cases).
Accuracy
时间窗: up to 14 days
The accuracy of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer. Namely, the accuracy = (total true negative cases+total true positive cases)/total number of cases.
次要结局
- Detection rate(up to 14 days)
- Sensitivity(up to 14 days)
- Specificity(up to 14 days)
研究者
Haitao Zhou
Clinical Professor
National Cancer Center, China