Status:
RECRUITING
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking Union Medical College Hospital
China-Japan Friendship Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 i...
Detailed Description
The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum...
Eligibility Criteria
Inclusion
- Patient age between 18-75 years.
- Colonic biopsy pathology confirms adenocarcinoma.
- At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
1384 Patients enrolled
Trial Details
Trial ID
NCT06146946
Start Date
December 1 2023
End Date
December 1 2029
Last Update
March 26 2025
Active Locations (8)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100021
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
4
Chinese PLA General Hospital
Beijing, Beijng, China, 100141