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Cola

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.

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.

The 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.

Dissection of the No.253 lymph node

In the experimental group, the surgery is performed without dissection of the No.253 lymph node.

Omitting the dissection of the No.253 lymph node

Mingguang Zhang, Dr.

Qian Liu, Dr.

Yi Xiao, Dr.

Lei Zhou, Dr.

Aiwen Wu, Dr.

Xiaohui Du, Dr.

Minhua Zheng

Xinxiang Li, Dr.

Xinxiang Li

Ziqiang Wang, Dr.

Ziqiang Wang

Qian Liu

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.

The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical technique.

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial

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.

Total number of lymph nodes dissected in the pathology report

The proportion of short-term complications occurring within 30 days post-surgery

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)

Three months, six months, and one year postoperatively, evaluate patients' urinary and sexual functions using scales.

Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.

Overall survival refers to the length of time from the primary treatment that patients are still alive.

Peking Union Medical College Hospital

China-Japan Friendship Hospital

Chinese PLA General Hospital

Ruijin Hospital

Fudan University

West China Hospital

Peking University Cancer Hospital & Institute

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Colonic Diseases

Neoplastic Processes

Patients underwent curative surgery with dissection of No.253 Lymph node

Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.

Laparoscopic colorectal surgery

The goal of this observational study is to learn about the the pattern of metastasis of the No.253 lymph node in colorectal cancer. The main questions it aims to answer are: 1. What are the risk factors for metastasis to the No.253 lymph node? 2.What is the prognosis for patients with metastasis to the No.253 lymph node? Patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the No.253 lymph node are included in this study

The No. 253 lymph node (also named as apical lymph node of inferior mesenteric artery), as the third station in the inferior mesenteric artery lymphatic system, plays a vital role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They serve as the last barrier for tumor metastasis from regional to distant sites. The definition of the range of the No.253 lymph node primarily follows the Japanese Colorectal Cancer Treatment Guidelines: the medial boundary is the segment from the root of the inferior mesenteric artery to the origin of the left colic artery, the caudal boundary is from the origin of the left colic artery to the intersection with the inferior mesenteric vein, the lateral boundary is the outer margin of the inferior mesenteric vein, and the cranial boundary is from the horizontal section of the duodenum to the beginning of the jejunum. However, the pattern of metastasis of the No.253 lymph node in colorectal cancer remains unclear, with most studies being retrospective and showing significant differences in results. Therefore, the investigator plans to be the first internationally to carry out this retrospective, registry-based study to determine the metastasis pattern to the No. 253 lymph node in colorectal cancer. This will provide definitive clinical evidence for D3 lymph node dissection in colorectal surgery.

Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

Real World Registry Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

Pathologically confirmed tumor cell infiltration in the No.253 lymph node

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)	NCT06146946	Rectal Cancer	Dissection of t... Omitting the di...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer	NCT06135571	Colorectal Canc... Lymph Node Meta...	Laparoscopic co...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for no.253 lymph node