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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

Qualifiers

Patient age between 18-75 years.

Colonic biopsy pathology confirms adenocarcinoma.

At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.

At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.

Disqualifiers

Previous history of malignant colorectal tumors.

Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.

Imaging diagnosis of distant metastasis.

Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.

Trial design

Treatments tested in this trial

  • Dissection of the No.253 lymph node
  • Omitting the dissection of the No.253 lymph node

Treatment groups

1,384 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking Union Medical College Hospital

Collaborator

China-Japan Friendship Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

Ruijin Hospital

Collaborator

Fudan University

Collaborator

West China Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator