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

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.

Conditions

• Rectal Cancer

Interventions

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Qian Liu · Cancer Hospital Chinese Academy of Medical Science

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2026-12-01

Completion

2029-12-01

Countries

• China

Study Locations