RecruitingNot ApplicableNCT06146946

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

1,384 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines the safety of skipping the removal of a particular set of lymph nodes (called No. 253 nodes, near the root of a major blood vessel) during surgery for mid-to-low rectal cancer, to see if this less extensive surgery has similar outcomes with fewer side effects. **You may be eligible if...** - You are between 18 and 75 years old - Your rectal cancer has been confirmed as adenocarcinoma by biopsy - The bottom of your tumor is 7 cm or less from the anus - Your tumor is at an early-to-intermediate stage (T3 or below) with no enlarged lymph nodes at the blood vessel root and fewer than 3 lymph nodes involved nearby - You are willing to have surgery **You may NOT be eligible if...** - You have had a previous malignant colorectal cancer - Your cancer is a special subtype called mucinous adenocarcinoma or signet ring cell carcinoma - Imaging shows your cancer has already spread to distant organs - You have had many prior abdominal surgeries or severe adhesions - You need emergency surgery due to obstruction, perforation, or bleeding - You have had another cancer in the past 5 years - You are in poor general health (ASA ≥IV or ECOG ≥2) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDissection 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.

PROCEDUREOmitting 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

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NCT06146946


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