Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Neoplasms, Fluorescence, Lymph Node Excision

Intervention / Treatment
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* Procedure: lymph node dissection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D2 lymph node dissection<br>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. | Procedure: lymph node dissection<br>* The extent of lymph node dissection varies between groups<br>* Other names: Radical operation for rectal cancer and sigmoid Cancer;|
| Active Comparator: D3 lymph node dissection<br>Thorough dissection of lymph nodes in the D3 region. | Procedure: lymph node dissection<br>* The extent of lymph node dissection varies between groups<br>* Other names: Radical operation for rectal cancer and sigmoid Cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months. | 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 | Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months. | The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph node resection | The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results | Until the pathological result is available , an average of 14 days. | 
| Blood loss | Blood loss is defined as intraoperative blood loss and measured in milliliters(ml). | Until the end of the operation, an average of 8 hours. | 
| Complications | Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency. | Until the patient recovered and was discharged from the hospital, an average of 10 days. | 
| Hospital stay after surgery | Hospital stay after surgery is defined as the length of time from the end of surgery | Until the patient recovered and was discharged from the hospital, an average of 10 days. | 
| Function score | Function score includes International Prostate Symptom Score, low anterior resection syndrome score and International Index of Erectile Function-5 score, which are used for assess the physical function. | Until one year after the patient's surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Fluorescence laparoscopic navigation, Lymph node dissection