Status:
NOT_YET_RECRUITING
Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 preservat...
Detailed Description
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 canc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
1596 Patients enrolled
Trial Details
Trial ID
NCT06956976
Start Date
June 1 2025
End Date
June 1 2031
Last Update
May 4 2025
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032