Clinical trial NCT06956976: Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer
Official title: Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Robotic Surgery
No. 253 lymph node
lymph node dissection
disease-free survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 1596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 preservation. The 3-year disease-free survival rates of these two surgical approaches will be compared.

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 cancer. It aims to evaluate both short-term safety and long-term efficacy. The main questions it seeks to answer are:

1. Does preserving IMA-LN achieve non-inferior 3-year disease-free survival (DFS) compared to IMA-LN dissection?
2. 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:

1. 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.
2. 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.

Participants will:

1. Be randomly assigned to either the preservation or dissection group. Receive standardized preoperative evaluations (imaging, biopsies) and postoperative follow-up for 3 years.
2. Undergo regular clinical assessments, including tumor marker tests, imaging (CT/MRI), colonoscopy, and quality-of-life questionnaires (evaluating urinary/sexual/defecation function).
3. Have surgical outcomes (e.g., complications, lymph node counts) and survival data recorded.

The trial aims to provide high-level evidence for optimizing surgical strategies in mid/low rectal cancer treatment.

Eligibility criteria: 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 outcomes:
measure: 3-year disease-free survival rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: 30-day postoperative complication rate
timeFrame: 30 days after surgery
measure: Urinary function
timeFrame: 1 year after surgery
measure: Male sexual function
timeFrame: 1 year after surgery
measure: Female sexual function
timeFrame: 1 year after surgery
measure: Defecation function
timeFrame: 1 year after surgery
measure: 3-year locoregional recurrence rate
timeFrame: 3 years after surgery
Other outcomes:
measure: Intraoperative complication rate
timeFrame: 30 days after surgery
measure: Open conversion rate
timeFrame: 30 days after surgery
measure: Operative time
timeFrame: 30 days after surgery
measure: Estimated intraoperative blood loss
timeFrame: 30 days after surgery
measure: Blood transfusion rate
timeFrame: 30 days after surgery
measure: Protective stoma rate
timeFrame: 30 days after surgery
measure: Macroscopic completeness of resection
timeFrame: 30 days after surgery
measure: Proximal resection margin distance
timeFrame: 30 days after surgery
measure: Distal resection margin distance
timeFrame: 30 days after surgery
measure: Distal resection margin positivity rate
timeFrame: 30 days after surgery
measure: Circumferential resection margin positivity rate
timeFrame: 30 days after surgery
measure: Number of lymph nodes harvested
timeFrame: 30 days after surgery
measure: Number of No.253 lymph nodes harvested
timeFrame: 30 days after surgery
measure: Number of positive lymph nodes
timeFrame: 30 days after surgery
measure: Number of positive No. 253 lymph nodes
timeFrame: 30 days after surgery
measure: Postoperative mortality rate
timeFrame: 30 days after surgery
measure: 30-day readmission rate
timeFrame: 30 days after surgery
measure: 30-day reoperation rate
timeFrame: 30 days after surgery
measure: Time to first flatus
timeFrame: 30 days after surgery
measure: Time to first liquid diet
timeFrame: 30 days after surgery
measure: Time to first semi-solid diet
timeFrame: 30 days after surgery
measure: Time to first defecation
timeFrame: 30 days after surgery
measure: Time to first autonomous urination
timeFrame: 30 days after surgery
measure: Postoperative hospital stay
timeFrame: 30 days after surgery
measure: 3-year overall survival rate
timeFrame: 3 years after surgery
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, Prof.
role: STUDY_CHAIR
References: