Trial Title:
Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
NCT ID:
NCT05730595
Condition:
Colorectal Neoplasms
Fluorescence
Lymph Node Excision
Conditions: Official terms:
Colorectal Neoplasms
Sigmoid Neoplasms
Conditions: Keywords:
Colorectal cancer
Fluorescence laparoscopic navigation
Lymph node dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
lymph node dissection
Description:
The extent of lymph node dissection varies between groups
Arm group label:
D2 lymph node dissection
Arm group label:
D3 lymph node dissection
Other name:
Fluorescence-guided laparoscopic surgery
Other name:
Radical operation for rectal cancer and sigmoid Cancer
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230001
Country:
China
Contact:
Last name:
Hanhui Yao, Dr.
Phone:
13505698955
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
The First Affiliated Hospital of Chengdu Medical College
Address:
City:
Chengdu
Zip:
610500
Country:
China
Contact:
Last name:
Jiangwei Xiao, Dr.
Phone:
17311394528
Facility:
Name:
Fujian Province Tumor Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Contact:
Last name:
Chunkang Yang, Dr.
Phone:
13509333116
Facility:
Name:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Contact:
Last name:
Dechang Diao
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510320
Country:
China
Contact:
Last name:
Deqing Wu, Dr.
Phone:
13902301120
Facility:
Name:
Nanfang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Contact:
Last name:
Haijun Deng, Dr.
Phone:
13189096629
Facility:
Name:
Hebei Medical University Fourth Hospital
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Harbin Medical University
Address:
City:
Haerbin
Zip:
150001
Country:
China
Facility:
Name:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Contact:
Last name:
Hao Wang, Dr.
Phone:
18602513286
Facility:
Name:
Jiangxi Provincial Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Contact:
Last name:
Bo Yi, Dr.
Phone:
13517007527
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Contact:
Last name:
Quan Wang, Dr.
Phone:
13944810508
Facility:
Name:
Shengjing Hospital
Address:
City:
Shenyang
Zip:
110004
Country:
China
Contact:
Last name:
Hong Zhang, Dr.
Phone:
18940257919
Facility:
Name:
Qinghai University Affiliated Hospital
Address:
City:
Xining
Zip:
810001
Country:
China
Contact:
Last name:
Su Yan, Dr.
Phone:
13519768807
Facility:
Name:
Binzhou Medical University
Address:
City:
Binzhou
Zip:
256603
Country:
China
Contact:
Last name:
Hong Jiang, Dr.
Phone:
155 6436 6177
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Guoxiang Cai, Dr.
Phone:
13611831623
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Contact:
Last name:
Haiyi Liu, Dr.
Phone:
15802513619
Facility:
Name:
The Second People's Hospital of Yibin
Address:
City:
Yibin
Zip:
644000
Country:
China
Contact:
Last name:
Miao Wu, Dr.
Phone:
13990905852
Facility:
Name:
The second People's Hospital of Yunnan Province
Address:
City:
Kunming
Zip:
650021
Country:
China
Contact:
Last name:
Bo Li, Dr.
Phone:
137 0847 2035
Start date:
September 1, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Fujian Province Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Qinghai University
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Harbin Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Second People's Hospital of Yunnan Province
Agency class:
Other
Collaborator:
Agency:
Binzhou Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of University of Science and Technology of China
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Chengdu Medical College
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Yibin
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730595
