Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

Официальное название

A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer

Обзор

To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.

Подробное описание

Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.

This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.

Вмешательства

• Процедура lymph node dissection
  The extent of lymph node dissection varies between groups

Первичные конечные точки

• Disease-free survival [Срок оценки: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.]
• Overall survival [Срок оценки: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.]

Вторичные конечные точки (5)

• The number of lymph node resection [Срок оценки: Until the pathological result is available , an average of 14 days.]
• Blood loss [Срок оценки: Until the end of the operation, an average of 8 hours.]
• Complications [Срок оценки: Until the patient recovered and was discharged from the hospital, an average of 10 days.]
• Hospital stay after surgery [Срок оценки: Until the patient recovered and was discharged from the hospital, an average of 10 days.]
• Function score [Срок оценки: Until one year after the patient's surgery]

Критерии участия

Критерии включения

• Participants are aged 18-75;
• Colonoscopy biopsy confirms colorectal adenocarcinoma;
• Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
• The tumor is staged cT1-4aNxM0 by preoperative imaging;
• Participants have no local complications before surgery.

Критерии исключения

• Previous history of malignant colorectal tumor;
• Multiple primary colorectal tumors;
• Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
• Patients undergoing neoadjuvant therapy before surgery;
• With contraindications to laparoscopic surgery;
• Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
• Other malignancies were diagnosed within the past 5 years;
• History of severe mental illness;
• Pregnant or lactating women;
• With uncontrolled infection before surgery.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 19 центров

• The First Affiliated Hospital of University of Science and Technology of China — Хэфэй
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• The First Affiliated Hospital of Chengdu Medical College — Чэнду
• Fujian Province Tumor Hospital — Фучжоу
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Nanfang Hospital of Southern Medical University — Гуанчжоу
• Hebei Medical University Fourth Hospital — Shijiazhuang
• … и ещё 11 центров

Идентификаторы

NCT: NCT05730595 · NCC20231

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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