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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences • ClinicalTrials.gov ID: NCT06146946

Registry updated: 2026-09-15
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Description

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.

Interventions

  • Dissection of the No.253 lymph node (Procedure)
    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.
  • Omitting the dissection of the No.253 lymph node (Procedure)
    In the experimental group, the surgery is performed without dissection of the No.253 lymph node.

Eligibility criteria

Inclusion Criteria: 1. Patient age between 18-75 years. 2. Colonic biopsy pathology confirms adenocarcinoma. 3. The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis. 4. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3. 5. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery. 6. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three. 7. Strong willingness for surgery and signed informed consent. Exclusion Criteria: 1. Previous history of malignant colorectal tumors. 2. Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma. 3. Imaging diagnosis of distant metastasis. 4. Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions. 5. Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery. 6. Extensive lesions not amenable to R0 resection. 7. Diagnosed with other malignancies within the past five years. 8. ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2. 9. Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery. 10. History of severe mental illness. 11. Pregnant or breastfeeding women.

Conditions

Rectal Cancer

Locations

  • 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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record