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

Recruiting now · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT06146946

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

1384

Starts

2023-12-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
• At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
• Strong willingness for surgery and signed informed consent.

You may not qualify if…

• 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.
• Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
• Extensive lesions not amenable to R0 resection.
• Diagnosed with other malignancies within the past five years.
• ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.
• Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
• History of severe mental illness.
• Pregnant or breastfeeding women.

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Chaoyang District, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• Chinese PLA General Hospital — Beijing, Beijng, China
• West China Hospital Sichuan University — Chengdu, Sichuan, China
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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