Safety of omitting dissection of specific lymph nodes in rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety of not dissecting the No.253 lymph nodes during mid and low rectal cancer surgeries. It aims to determine if patients can achieve similar long-term survival rates with or without this dissection. Participants will undergo laparoscopic rectal radical resection, with some having the No.253 lymph node dissection omitted. The study is being conducted across eight medical centers in China to gather robust evidence on this surgical approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Chaoyang District, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Chinese PLA General Hospital
  Beijing, Beijng, China Not yet recruiting

Study contacts

• Principal investigator: Qian Liu — Cancer Hospital Chinese Academy of Medical Science
• Study coordinator: Mingguang Zhang, Dr.
• Email: zmgslimshady@163.com
• Phone: +8613261967603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.