About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age between 18-75 years.
Colonic biopsy pathology confirms adenocarcinoma.
The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
Disqualifiers
Previous history of malignant colorectal tumors.
Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
Imaging diagnosis of distant metastasis.
Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
Trial design
Parallel
Treatments tested in this trial
Dissection of the No.253 lymph node
Procedure/SurgeryThe range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node.
Omitting the dissection of the No.253 lymph node
Procedure/SurgeryIn the experimental group, the surgery is performed without dissection of the No.253 lymph node.
Treatment groups
Trial outcomes
Primary outcomes
3-year disease free survival rate
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
Secondary outcomes
Number of harvested lymph nodes
Total number of lymph nodes dissected in the pathology report
Incidence of postoperative complications
The proportion of short-term complications occurring within 30 days post-surgery
Intraoperative blood loss
Total blood loss during the surgery
Operative duration
total time spent performing a surgical procedure. This time is typically measured from the moment the surgery begins (marked by the initial incision) to its conclusion (marked by the closure of the surgical wound)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Peking Union Medical College Hospital
Collaborator
China-Japan Friendship Hospital
Collaborator
Fudan University
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Shanghai 10th People's Hospital
Collaborator
Affiliated Hospital of Qinghai University
Collaborator
First Hospital of China Medical University
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Qianfoshan Hospital
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
Yuncheng Central Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
The First Hospital of Jilin University
Collaborator
Beijing Friendship Hospital
Collaborator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborator
Shandong Provincial Hospital
Collaborator
Yunnan Cancer Hospital
Collaborator
The Fourth Affiliated Hospital of Harbin Medical University
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Beijing Chao Yang Hospital
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Army Medical Center of PLA
Collaborator
Zhejiang Cancer Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Sixth Hospital of Shanxi Medical University
Collaborator
Shengjing Hospital
Collaborator
Tang-Du Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Ruijin Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Tianjin Union Medical Center
Collaborator