Applications of Near-infrared Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- success rate of IMA fluorescence imaging
研究概览
简要总结
To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.
详细描述
Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph node imaging techniques can effectively increase the number of harvested lymph nodes in gastric and colorectal cancer surgeries . However, there remains a scarcity of research specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253 lymph nodes. Most existing studies have been retrospective analyses, and the need for prospective studies is evident. Further clinical research is crucial to explore the successful application of fluorescence lymph node imaging combined with indocyanine green (ICG) fluorescence angiography and its multifunctional fusion. To address this gap, investigators plan to conduct a randomized controlled trial comparing the outcomes between the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery. Specifically, investigators focus will be on the preservation of the left colic artery (LCA) and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify surgical procedures, enhance surgical safety, and provide substantial evidence for the further promotion and adoption of this technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients aged between 18 and 75 years
- •Colonoscopic biopsy confirmed colorectal adenocarcinoma
- •The tumor was located in the rectum or upper rectum, and the surgical method was Dxion
- •No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
- •Preoperative imaging diagnosis was cT1-4aNxM0
- •The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
- •Sign the informed consent form
排除标准
- •Previous surgical history of malignant colorectal tumors
- •The surgical methods were combined abdominoperineal resection, Hartman operation and ISR operation
- •There are contraindication of laparoscopic surgery, such as severe cardiopulmonary insufficiency
- •Patients who have undergone multiple abdominal and pelvic surgeries or extensive abdominal adhesion
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other emergency operations
- •ASA grade ≥IV and/or ECOG physical status score ≥2 points
- •Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery
- •Have a history of serious mental illness
- •Patients with uncontrolled infection before operation
结局指标
主要结局
success rate of IMA fluorescence imaging
时间窗: From the beginning to the end of the surgery.
ICG solution was prepared at a concentration of 2.5 g/L. A dose of 0.05 mg-0.10 mg/kg body weight of ICG was administered intravenously through a peripheral or central vein. Before the injection of ICG, the fluorescence laparoscope was set to the original fluorescence mode to monitor the IMA region in real-time.Record the success or failure rate of IMA fluorescence imaging in the observation group. Classify the successful IMA fluorescence imaging results into four different types according to the Morro classification and calculate the proportion of each type in successful imaging.
次要结局
- Left colic artery retention rate(From the beginning to the end of the surgery.)
- Operation time(From the beginning to the end of the surgery.)
- Protective ostomy rate(From the beginning to the end of the surgery.)
- Complication rate within 30 days after operation(within 30 days after operation.)
- Incidence of IMA bleeding events(From the beginning to the end of the surgery.)
- No.253 lymph node dissection time(From the beginning to the end of the surgery.)
- Intraoperative blood loss(From the beginning to the end of the surgery.)
- Assessment of postoperative anal function urinary function within 30 days(Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.)
- Measurement of residual urine volume in the bladder.(On the day the catheter was removed after surgery.)
- Arterial development time(From the beginning to the end of the surgery.)
研究者
Jianqiang Tang
Associate professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences