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

Официальное название

Preservation Versus Dissection of Inferior Mesenteric Artery Lymph Nodes of Robotic Radical Resection for Mid/Low Rectal Cancer (REAL2): A Multicenter Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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).
• Процедура 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).

Первичные конечные точки

• 3-year disease-free survival rate [Срок оценки: 3 years after surgery]

Вторичные конечные точки (6)

• 30-day postoperative complication rate [Срок оценки: 30 days after surgery]
• Urinary function [Срок оценки: 1 year after surgery]
• Male sexual function [Срок оценки: 1 year after surgery]
• Female sexual function [Срок оценки: 1 year after surgery]
• Defecation function [Срок оценки: 1 year after surgery]
• 3-year locoregional recurrence rate [Срок оценки: 3 years after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital Fudan University — Шанхай

Идентификаторы

NCT: NCT06956976 · REAL2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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