RecruitingNot ApplicableNCT06146946

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

1,384 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

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 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria11

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.

Interventions

PROCEDUREDissection of the No.253 lymph node

The range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node.

PROCEDUREOmitting the dissection of the No.253 lymph node

In the experimental group, the surgery is performed without dissection of the No.253 lymph node.