Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
• At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
• At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
• At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
• At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
• Strong willingness for surgery and signed informed consent.
Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Chinese PLA General Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
West China Hospital Sichuan University
NOT_YET_RECRUITING
Chengdu
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Mingguang Zhang, Dr.
zmgslimshady@163.com
+8613261967603
Backup
Qian Liu, Dr.
fcwpumch@163.com
13601008906
Time Frame
Start Date:2023-12-01
Estimated Completion Date:2029-12-01
Participants
Target number of participants:1384
Treatments
Experimental: Omitting dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery.
Active_comparator: Dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery.
Collaborators: China-Japan Friendship Hospital, Peking Union Medical College Hospital, Ruijin Hospital, West China Hospital, Fudan University, Peking University Cancer Hospital & Institute, Chinese PLA General Hospital
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences