Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
Recruiting · NCT06146946 · Interventional (participants receive a specific treatment) · Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Dissection of the No.253 lymph nodeOmitting the dissection of the No.253 lymph node
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
8 locations listed.
- 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