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

NCT ID: NCT06956976

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2031-06-01

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Preservation of Inferior Mesenteric Artery Root Lymph Node

Intervention Type: PROCEDURE

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).

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).

Group Type: PLACEBO_COMPARATOR

Dissection of Inferior Mesenteric Artery Root Lymph Node

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

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).

Intervention Type: PROCEDURE

Other Intervention Names

IMA-LN Dissection; IMA-LN Preservation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Chair of Colorectal Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Xu, Prof.

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jianmin Xu, Prof.

Role: CONTACT

xujmin@aliyun.com

+86 13501984869

Qingyang Feng, M.D.

Role: CONTACT

fqy198921@163.com

86-021-64041990

Facility Contacts

Jianmin Xu, Prof.

Role: primary

xujmin@aliyun.com

+86-021-64041990

Qingyang Feng, Dr.

Role: backup

fqy198921@163.com

+86-021-64041990

Other Identifiers

REAL2

Identifier Type: -

Identifier Source: org_study_id