Clinical trial NCT05730595: Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Fluorescence
Lymph Node Excision
Keywords: Colorectal cancer
Fluorescence laparoscopic navigation
Lymph node dissection
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Fujian Province Tumor Hospital
name: Guangdong Provincial People's Hospital
name: Shengjing Hospital
name: Affiliated Hospital of Qinghai University
name: Hebei Medical University Fourth Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Jiangxi Provincial Cancer Hospital
name: The First Hospital of Jilin University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Shanxi Province Cancer Hospital
name: Nanfang Hospital, Southern Medical University
name: Second People's Hospital of Yunnan Province
name: Binzhou Medical University
name: The First Affiliated Hospital of University of Science and Technology of China
name: First Affiliated Hospital of Chengdu Medical College
name: The Second People's Hospital of Yibin
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2023-02-16
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
measure: Overall survival
timeFrame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
Secondary outcomes:
measure: The number of lymph node resection
timeFrame: Until the pathological result is available , an average of 14 days.
measure: Blood loss
timeFrame: Until the end of the operation, an average of 8 hours.
measure: Complications
timeFrame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
measure: Hospital stay after surgery
timeFrame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
measure: Function score
timeFrame: Until one year after the patient's surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Chengdu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Chengdu
city: Fuzhou
country: China
facility: Fujian Province Tumor Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Haerbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Binzhou
country: China
facility: Binzhou Medical University
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
city: Kunming
country: China
facility: The second People's Hospital of Yunnan Province
state: Yunnan
Study officials:
References: