Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
NCT ID: NCT05730595
Last Updated: 2023-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
550 participants
INTERVENTIONAL
2023-09-01
2027-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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D2 lymph node dissection
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.
lymph node dissection
The extent of lymph node dissection varies between groups
D3 lymph node dissection
Thorough dissection of lymph nodes in the D3 region.
lymph node dissection
The extent of lymph node dissection varies between groups
Interventions
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lymph node dissection
The extent of lymph node dissection varies between groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Fujian Province Tumor Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Shengjing Hospital
OTHER
Affiliated Hospital of Qinghai University
OTHER
Hebei Medical University Fourth Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
The First Hospital of Jilin University
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Shanxi Province Cancer Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Second People's Hospital of Yunnan Province
OTHER
Binzhou Medical University
OTHER
The First Affiliated Hospital of University of Science and Technology of China
OTHER
First Affiliated Hospital of Chengdu Medical College
OTHER
The Second People's Hospital of Yibin
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jianqiang Tang
Associate professor
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital
Shenyang, Liaoning, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Binzhou Medical University
Binzhou, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
The second People's Hospital of Yunnan Province
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Hanhui Yao, Dr.
Role: primary
Jiangwei Xiao, Dr.
Role: primary
Chunkang Yang, Dr.
Role: primary
Dechang Diao
Role: primary
Deqing Wu, Dr.
Role: primary
Haijun Deng, Dr.
Role: primary
Hao Wang, Dr.
Role: primary
Bo Yi, Dr.
Role: primary
Quan Wang, Dr.
Role: primary
Hong Zhang, Dr.
Role: primary
Su Yan, Dr.
Role: primary
Hong Jiang, Dr.
Role: primary
Guoxiang Cai, Dr.
Role: primary
Haiyi Liu, Dr.
Role: primary
Miao Wu, Dr.
Role: primary
Bo Li, Dr.
Role: primary
Other Identifiers
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NCC20231
Identifier Type: -
Identifier Source: org_study_id
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