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RECRUITING
NCT06146946
NA

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1384

Start Date

2023-12-01

Completion Date

2029-12-01

Last Updated

2025-03-26

Healthy Volunteers

No

Conditions

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.

Locations (8)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijng, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang District, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital Sichuan University

Chengdu, Sichuan, China