Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,384
- 试验地点
- 8
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
详细描述
The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical 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
- 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
- •Patient age between 18-75 years.
- •Colonic biopsy pathology confirms adenocarcinoma.
- •The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
- •At initial treatment, imaging diagnoses the tumor T stage as less than or equal to
- •At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
- •At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
- •Strong willingness for surgery and signed informed consent.
排除标准
- •Previous history of malignant colorectal tumors.
- •Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
- •Imaging diagnosis of distant metastasis.
- •Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
- •Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
- •Extensive lesions not amenable to R0 resection.
- •Diagnosed with other malignancies within the past five years.
- •ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥
- •Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
- •History of severe mental illness.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Omitting dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery.
干预措施: Omitting the dissection of the No.253 lymph node (Procedure)
Dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery.
干预措施: Dissection of the No.253 lymph node (Procedure)
结局指标
主要结局
3-year disease free survival rate
时间窗: 3 years after surgery
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
次要结局
- Postoperative urination and sexual function(1 year after surgery)
- 3-year overall survival rate(3 years after surgery)
- Incidence of postoperative complications(30 days after surgery)
- 3-year local recurrence rate(3 years after surgery)
- Number of harvested lymph nodes(About 10 days after surgery)
- Intraoperative blood loss(Intraoperative)
- Operative duration(Intraoperative)
- Rate of conversion to open surgery(From initial skin incision to skin closure at the conclusion of the index operation (full intraoperative period).)
研究者
QIAN LIU
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences