NCT06146946

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,384 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Dissection of the No.253 lymph node	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.
PROCEDURE	Omitting the dissection of the No.253 lymph node	In the experimental group, the surgery is performed without dissection of the No.253 lymph node.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-12-01
• Completion: 2029-12-01
• First posted: 2023-11-27
• Last updated: 2025-03-26

Locations

8 sites across 1 country: China