Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06146946

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-03-26

1384

Participants Needed

8

Research Sites

313 weeks

Total Duration

On this page

Sponsors

C

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Colon biopsy confirms adenocarcinoma
  • Tumor lower edge is 7 cm or less from the anus by colonoscopy and imaging
  • Tumor T stage is 3 or less by imaging
  • No enlarged lymph nodes at the root of the inferior mesenteric artery by imaging
  • Three or fewer mesenteric metastatic lymph nodes by imaging
  • Strong willingness to undergo surgery and signed informed consent
Not Eligible

You will not qualify if you...

  • Previous malignant colorectal tumors
  • Biopsy shows mucinous adenocarcinoma or signet ring cell carcinoma
  • Distant metastasis diagnosed by imaging
  • History of multiple abdominal-pelvic surgeries or extensive abdominal adhesions
  • Complications requiring emergency surgery such as intestinal obstruction, perforation, or bleeding
  • Extensive lesions not suitable for complete tumor removal (R0 resection)
  • Other malignancies diagnosed within the past five years
  • ASA class IV or higher and/or ECOG performance score 2 or higher
  • Severe liver, kidney, heart, lung, coagulation dysfunctions, or serious underlying diseases preventing surgery
  • History of severe mental illness
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Not Yet Recruiting

3

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Not Yet Recruiting

4

Chinese PLA General Hospital

Beijing, Beijng, China, 100141

Not Yet Recruiting

5

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang District, China, 100021

Actively Recruiting

6

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Not Yet Recruiting

7

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

8

West China Hospital Sichuan University

Chengdu, Sichuan, China, 610044

Not Yet Recruiting

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Research Team

M

Mingguang Zhang, Dr.

CONTACT

Q

Qian Liu, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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