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
- Diseases
- Colorectal cancer
- 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
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.