Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer (FLORA-01)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Fluorescence; Lymph Node Excision; Colorectal Neoplasms

Treatments: Procedure: lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT05730595

NCC20231

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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550 participants in 2 patient groups

D2 lymph node dissection

Experimental group

Description:

The D2 lymph node region are dissected. And 1-3 lymph nodes of the D2 region will be selected for intraoperative frozen section. If no lymph node metastasis is found in freezing, the D3 region lymph nodes in the root of the submesenteric artery were preserved.

Treatment:

Procedure: lymph node dissection

D3 lymph node dissection

Active Comparator group

Description:

Thorough dissection of lymph nodes in the D3 region.

Treatment:

Procedure: lymph node dissection