Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

Not Applicable

Not yet recruiting

• Conditions: Colorectal Neoplasms; Fluorescence; Lymph Node Excision

• Registration Number: NCT05730595
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-26
• Last Update Posted: 2023-08-29
• Study Start: 2023-09-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 550

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood loss	Until the end of the operation, an average of 8 hours.	Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Complications	Until the patient recovered and was discharged from the hospital, an average of 10 days.	Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Hospital stay after surgery	Until the patient recovered and was discharged from the hospital, an average of 10 days.	Hospital stay after surgery is defined as the length of time from the end of surgery
Function score	Until one year after the patient's surgery	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.
The number of lymph node resection	Until the pathological result is available , an average of 14 days.	The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results

Trial Locations

Locations (19)

The First Affiliated Hospital of University of Science and Technology of China; 🇨🇳 Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chengdu Medical College; 🇨🇳 Chengdu, Chengdu, China

Fujian Province Tumor Hospital; 🇨🇳 Fuzhou, Fujian, China

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hebei Medical University Fourth Hospital; 🇨🇳 Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Haerbin, Heilongjiang, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

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