Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

Colorectal Neoplasms Clinical Trial

— FLORA-01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05730595
• Other study ID #: NCC20231
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: August 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jianqiang Tang, Dr.
• Phone: +8613661090036
• Email: doc_tjq[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: June 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Fluorescence
• Lymph Node Excision
• Sigmoid Neoplasms

Intervention

Procedure:
• lymph node dissection
The extent of lymph node dissection varies between groups

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Binzhou Medical University	Binzhou	Shandong
China	The First Hospital of Jilin University	Changchun	Jilin
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	The Second Affiliated Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui
China	The second People's Hospital of Yunnan Province	Kunming	Yunnan
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shengjing Hospital	Shenyang	Liaoning
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Qinghai University Affiliated Hospital	Xining	Qinghai
China	The Second People's Hospital of Yibin	Yibin	Sichuan

Sponsors (19)

Lead Sponsor

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Affiliated Hospital of Qinghai University, Binzhou Medical University, First Affiliated Hospital of Chengdu Medical College, Fudan University, Fujian Province Tumor Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial People's Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital, Nanfang Hospital, Southern Medical University, Second People's Hospital of Yunnan Province, Shanxi Province Cancer Hospital, Shengjing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of University of Science and Technology of China, The First Hospital of Jilin University, The Second Affiliated Hospital of Harbin Medical University, The Second People's Hospital of Yibin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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