Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
About this study
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.
- Condition
- Rectal Cancer
- Tested
- Dissection of the No.253 lymph node, Omitting the dissection of the No.253 lymph node
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Rectal Cancer
- 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 11
- 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
8 sites, 8 recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Chaoyang District, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijng, China
and 2 more sites on ClinicalTrials.gov
Contact
-
Mingguang Zhang, Dr.
+8613261967603 zmgslimshady@163.com
-
Qian Liu, Dr.
13601008906 fcwpumch@163.com
Potential match only. Final eligibility is determined by the study team.