Preservation Vs. Dissection of No. 253 Lymph Nodes of Robotic Resection for Mid/Low Rectal Cancer (REAL2)

Fudan University

Status: Begins enrollment this month

Conditions: Rectal Cancer

Treatments: Procedure: Dissection of Inferior Mesenteric Artery Root Lymph Node; Procedure: Preservation of Inferior Mesenteric Artery Root Lymph Node

Study type: Interventional

Funder types: Other

Identifiers

NCT06956976

REAL2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,596 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,596 participants in 2 patient groups, including a placebo group

IMA-LN Preservation

Active Comparator group

Description:

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).

Treatment:

Procedure: Preservation of Inferior Mesenteric Artery Root Lymph Node

IMA-LN Dissection

Placebo Comparator group

Description:

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).

Treatment:

Procedure: Dissection of Inferior Mesenteric Artery Root Lymph Node