Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,596
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival rate
研究概览
简要总结
In this study, patients with middle or low rectal cancer will receive robotic radical resection, and will be randomly assigned to receive inferior mesenteric artery lymph nodes dissection or preservation. The 3-year disease-free survival rates of these two surgical approaches will be compared.
详细描述
The goal of this clinical trial is to compare the outcomes of preserving versus dissecting inferior mesenteric artery root lymph nodes (IMA-LN) during robotic radical resection for mid/low rectal cancer. It aims to evaluate both short-term safety and long-term efficacy. The main questions it seeks to answer are:
- Does preserving IMA-LN achieve non-inferior 3-year disease-free survival (DFS) compared to IMA-LN dissection?
- Does preserving IMA-LN reduce postoperative complications (e.g., anastomotic leakage, urinary/defecation dysfunction) and improve quality of life?
Researchers will compare two surgical strategies:
- IMA-LN preservation group: No dissection of IMA root lymph nodes, with ligation of the inferior mesenteric artery (IMA) distal to the left colic artery.
- IMA-LN dissection group: Complete dissection of IMA root lymph nodes, with high or low ligation of the IMA.
Both groups will undergo robotic surgery following total mesorectal excision (TME) principles.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years and ≤80 years
- •Pathologically confirmed rectal adenocarcinoma by colonoscopic biopsy
- •Tumor located ≤10 cm from the anal verge
- •No metastasis at the root of the inferior mesenteric artery (IMA) and no lateral lymph node metastasis confirmed by pelvic ultrasound, contrast-enhanced CT, and/or PET-CT (diagnostic criteria per the 2024 Chinese Society of Clinical Oncology [CSCO] Guidelines)
- •No distant metastasis (including pelvic, peritoneal, hepatic, pulmonary, cerebral, skeletal, or distant lymph node metastasis) confirmed by imaging
- •Pelvic MRI and/or transrectal ultrasound confirming cT1-T3 N0-1 stage, or ycT1-T3 Nx after neoadjuvant therapy (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
- •No history of other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ)
- •Suitable for robotic surgery
- •Signed informed consent
排除标准
- •Clinical complete response after radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- •cT1N0 tumors suitable for local excision
- •Emergency surgery required due to acute bowel obstruction, hemorrhage, or perforation
- •Multiple primary colorectal malignancies
- •Familial adenomatous polyposis (FAP), Lynch syndrome, or inflammatory bowel disease
- •Concomitant conditions requiring concurrent colonic resection
- •American Society of Anesthesiologists (ASA) grade >III
- •Pregnancy or lactation
- •Preoperative short-course radiotherapy
- •Inability of the patient/family to comprehend the study protocol
研究组 & 干预措施
IMA-LN Preservation
Patients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), but preserving the lymph nodes at the root of the inferior mesenteric artery (IMA).
干预措施: Preservation of Inferior Mesenteric Artery Root Lymph Node (Procedure)
IMA-LN Dissection
Patients underwent robotic radical resection for rectal cancer, adhering to the principles of Total Mesorectal Excision (TME) or Tumor-Specific Mesorectal Excision (TSME), and dissecting the lymph nodes at the root of the inferior mesenteric artery (IMA).
干预措施: Dissection of Inferior Mesenteric Artery Root Lymph Node (Procedure)
结局指标
主要结局
3-year disease-free survival rate
时间窗: 3 years after surgery
The 3-year disease-free survival (DFS) rate was defined as the percentage of patients with no death and no locoregional recurrence and no distant metastases within 3 years postoperatively, assessed via imaging (contrast-enhanced CT/MRI, PET-CT) or histopathological confirmation (colonoscopy/biopsy).
次要结局
- Male sexual function(1 year after surgery)
- 30-day postoperative complication rate(30 days after surgery)
- Urinary function(1 year after surgery)
- Female sexual function(1 year after surgery)
- Defecation function(1 year after surgery)
- 3-year locoregional recurrence rate(3 years after surgery)
研究者
Xu jianmin
Chair of Colorectal Surgery Department
Fudan University