Starting soon
Not applicable
Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
Condition(s) studied
Rectal Cancer
Investigational drug(s) / intervention(s)
Dissection of Inferior Mesenteric Artery Root Lymph NodePreservation of Inferior Mesenteric Artery Root Lymph Node
Dissection of Inferior Mesenteric Artery Root Lymph Node: 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).
Preservation of Inferior Mesenteric Artery Root Lymph Node: 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).
Study summary
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.
Eligibility
Inclusion Criteria:
1. Age \>18 years and ≤80 years
2. Pathologically confirmed rectal adenocarcinoma by colonoscopic biopsy
3. Tumor located ≤10 cm from the anal verge
4. 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)
5. No distant metastasis (including pelvic, peritoneal, hepatic, pulmonary, cerebral, skeletal, or distant lymph node metastasis) confirmed by imaging
6. Pelvic MRI and/or transrectal ultrasound confirming cT1-T3 N0-1 stage, or ycT1-T3 Nx after neoadjuvant therapy (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
7. No history of other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ)
8. Suitable for robotic surgery
9. Signed informed consent
Exclusion Criteria:
1. Clinical complete response after radiotherapy, chemotherapy, immunotherapy, or targeted therapy
2. cT1N0 tumors suitable for local excision
3. Emergency surgery required due to acute bowel obstruction, hemorrhage, or perforation
4. Multiple primary colorectal malignancies
5. Familial adenomatous polyposis (FAP), Lynch syndrome, or inflammatory bowel disease
6. Concomitant conditions requiring concurrent colonic resection
7. American Society of Anesthesiologists (ASA) grade \>III
8. Pregnancy or lactation
9. Preoperative short-course radiotherapy
10. Inability of the patient/family to comprehend the study protocol
Primary outcome measure(s)
- 3-year disease-free survival rate — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Zhongshan Hospital Fudan University |
Shanghai |
Shanghai Municipality |
|