Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The number of cleared IMA root lymph nodes
研究概览
简要总结
Indocyanine green NIR imaging is valuable for lymph node dissection in D3 radical surgery for rectal cancer. It can guide the intraoperative improvement of lymph node dissection based on the preservation of LCA and peripheral autonomic nerves of IMA. This not only reduces the occurrence of postoperative complications and promotes rapid postoperative recovery, but also provides a more precise and individualized comprehensive treatment plan for patients after surgery. In addition，this trial also demonstrated that ICG is safe and feasible for use in rectal cancer
详细描述
The pathological data of 96 patients with rectal cancer from September 2020 - July 2022 were collected from the First Hospital of Qinhuangdao City.In 51 of these patients, ICG was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. The surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.The IMA root is treated with low ligation of the IMA, while lymph node dissection is performed while preserving the autonomic nerves around the IMA. The other 45 patients were not injected with ICG, and the procedure was performed as before.The occurrence of postoperative complications was recorded, and the detection of lymph nodes was also compared between the two groups, as well as the intraoperative situation and postoperative recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The preoperative colonoscopic pathological diagnosis was clearly rectal cancer and no malignant tumor in other sites.
- •Good preoperative general condition, no serious cardiopulmonary, hepatic, renal or other major comorbidities before surgery
- •Radical rectal cancer surgery with preservation of LCA and peripheral autonomic nerves of IMA in patients
- •No contraindications to surgery
- •No history of ICG or iodide allergy
排除标准
- 未提供
研究组 & 干预措施
non-ICG Group
Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection
干预措施: non-ICG (Other)
ICG Group
ICG was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. The surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.The IMA root is treated with low ligation of the IMA, while lymph node dissection is performed while preserving the autonomic nerves around the IMA
干预措施: ICG (Drug)
结局指标
主要结局
The number of cleared IMA root lymph nodes
时间窗: immediately after surgery
A group of lymph nodes surrounding the inferior mesenteric artery between the origin of the artery and the left colic artery
The total number of cleared lymph nodes
时间窗: immediately after surgery
The sum of IMA root lymph nodes and lymph nodes surrounding the tumor area
The number of positive lymph nodes
时间窗: immediately after surgery
There are metastatic tumor cells in the lymph nodes
次要结局
- Quality of postoperative recovery(Up to 7 days after surgery)
- The incidence of postoperative complications(Up to 7 days after surgery)