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NCT06146946Recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1384 (estimated)
First submitted
18 Nov 2023
Start date
1 Dec 2023
Primary completion date
1 Dec 2026
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT06146946

What you commit to

  • Study type: Interventional
  • Planned participants: 1384
  • From 1 Dec 2023 to the primary completion date, 1 Dec 2026
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Extensive lesions not amenable to R0 resection.

Other illness

  • Previous history of malignant colorectal tumors.
  • Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
  • Diagnosed with other malignancies within the past five years.
  • Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
  • History of severe mental illness.

Other

  • 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.
  • ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.
  • Pregnant or breastfeeding women.

Who the study is looking for

  • Patient age between 18-75 years.
  • Colonic biopsy pathology confirms adenocarcinoma.
  • The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
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BeijingChinaNot yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaRecruiting
Chinese PLA General Hospital
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BeijingChinaNot yet recruiting
China-Japan Friendship Hospital
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BeijingChinaNot yet recruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaNot yet recruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.